676 matches.
- EventsDiabetes Technology Meeting: Who Can Sell Your Data - a United States Perspective1 minute read
- EventsNCURA Annual Meeting: Key Challenges in Navigating Research Misconduct Proceedings1 minute read
- EventsMultipurpose Prevention Technology (MPT) Summit: Experiences from Other Fields to Help Address MPT Roadblocks1 minute read
- EventsCIRS: Vaccines for Adults – Increasing Access and Uptake1 minute read
- BlogsFDA Wins Mifepristone Case, NLRB Denied Lower Injunctive Relief Standards, and “Trump Too Small” Denied Trademark - SCOTUS Today7 minute read
- Media CoverageBradley Merrill Thompson Cited in “AI Regulation: Global Picture Balances Innovation and Insight”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Experts Advise Against Prescriptive FDA Policies for Regulating AI”3 minute read
- Media CoverageRachel Snyder Good Quoted in “A First in State AI Law”2 minute read
- BlogsLitigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast41 minute read
- Litigating Nutrition: Class Action Battles Over Dietary Supplements
- FDA Releases Laboratory-Developed Tests Final Rule
- Media CoverageJames Boiani Quoted in “Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval”5 minute read
- EventsABA 2024 HIV Law & Practice Conference: HIV Healthcare – Developments and Possibilities1 minute read
- Events2024 NCICP: Legal Landscape for Vaccination1 minute read
- PublicationsThe Legal and Reputational Risks Associated with Greenwashing3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Warned of Removing Guidance Comment Period in Proposed Plan”2 minute read
- EventsLife Sciences AI Summit: Navigating FDA and EMA Directives - Shaping AI’s Role in the Life Sciences2 minute read
- PublicationsHealth Care M&A Insights: Q4 2023 & Outlook for 2024 Deal Activity4 minute read
- Media CoverageBradley Merrill Thompson Discusses “Problematic Guidance Patterns Remain at FDA”2 minute read
- EventsCurrent Developments in Digital Health Technology and Regulation: More Than Medical Devices - Development and Use of Companion Apps for Pharmaceutical Products and Beyond1 minute read
- EventsFundamentals of Digital Health Regulation: What Advertising and Promotion Requirements Apply?1 minute read
- PublicationsEnsure Equity and Feasibility in Updating Meningococcal Vaccine Recommendations2 minute read
- Media CoverageBradley Merrill Thompson Discusses Clinical Decision Support, Medical Devices, and AI in Yale Video1 minute read
- Media CoverageJames Boiani Quoted in “Clinical Lab Consolidation Continues in 2023 While Key Policy Questions Go Unresolved”2 minute read
- Media CoverageJames Boiani Quoted in “FDA Braces for High Court, Final Rule Moves in Election Year”3 minute read
- EventsPRIM&R Annual Conference: Ethical, Legal, and Regulatory Challenges of Conducting Research on Psychedelic Substances1 minute read
- EventsWorld Vaccine Congress West Coast: How Are NITAGs & HTAs Thinking About Novel Antibody Products?1 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2024 Promotions6 minute read
- BlogsSharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance14 minute read
- EventsBBA: New Rules to Research Misconduct? How the Office of Research Integrity’s Proposed Revisions to PHS Rules on Research Misconduct May Affect You2 minute read
- Media CoverageJames Boiani Quoted in “FDA Moving Quickly on LDT Rulemaking as 2024 Elections, 2027 User Fee Renewal Loom”2 minute read
- Media CoverageRachel Snyder Good Quoted in “'Devil's in the Details' of Biden's AI Health Plans, Experts Say”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The Problem with FDA's Warning to Abiomed”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AI vs. the Health Bureaucracy”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AI Has Arrived in Your Doctor’s Office. Washington Doesn’t Know What to Do About It.”4 minute read
- EventsFDA's LDT Proposed Rule: A Discussion1 minute read
- PublicationsNavigating the Medtech GenAI Journey: A Policy Primer2 minute read
- Media CoverageJames Boiani Quoted in “Proposed FDA Rule Sets Stage for New Round of Battle Over LDT Regulation”5 minute read
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
- Media CoverageJames Boiani Quoted in “FDA Wants Oversight of Lab-Developed Tests”2 minute read
- Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
- BlogsFDA Oversight of AI Software Developed by Health Care Providers23 minute read
- PublicationsDietary Supplement Makers Face "Misbranding" Minefield, Need FDA Guidance7 minute read
- BlogsFDA’s LDT Proposed Rule Heads to the White House2 minute read
- BlogsTAKE TWO: CMS’s Second Attempt to Streamline Breakthrough Device Coverage Limited to 5 Devices Per Year26 minute read
- Events11th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements: Class Action Boot Camp2 minute read
- Post-Dobbs: One Year Later
- Media CoverageBradley Merrill Thompson Quoted in “FDA, Industry Coalition Still at Odds Over September 2022 CDS Final Guidance”2 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2023 Southern California Rising Stars List6 minute read
- PublicationsBy Leaving "Therapeutic Alternatives" Undefined, CMS Tilts the Playing Field of Drug Price Negotiations3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Ready or Not, AI Chatbots Are Coming to Hospitals”3 minute read
- PublicationsWhy a Data Scientist Needs a Lawyer to Correct Algorithmic Discrimination4 minute read
- Direct Access Laboratory Testing: Physician Orders and Specimen Collection
- Legal and Regulatory Landscape for Psychedelics as Therapies
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance Allows AI/ML Devices to Evolve Without Requiring New Submissions”5 minute read
- PublicationsBradley Merrill Thompson Quoted in “FDA’s Human Factors Draft Draws Fire for Introduction of ‘Critical Task’ Concept”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Outlines Plan for Digital Health Technologies for Clinical Trials”4 minute read
- PublicationsReminder of March 31 “Right to Try” Reporting Deadline8 minute read
- Firm AnnouncementsEpstein Becker Green Recognized Among Top 10 Largest Health Care Law Firms by Modern Healthcare2 minute read
- PublicationsIs Federal Trade Commission at War with the Dietary Supplement Industry?2 minute read
- Media CoverageJames Boiani Quoted in “FDA Resumes Move to Regulate LDTs, Likely Setting Up Legal Battle with Lab Industry”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Growth of AI in Mental Health Raises Fears of Its Ability to Run Wild”4 minute read
- EventsMachine Learning in Healthcare: Regulatory Requirements, Reimbursement Challenges, Privacy, and Security Risks1 minute read
- Direct Access Laboratory Testing: Reimbursement & Compliance
- Media CoverageBradley Merrill Thompson Quoted in “The FDA Plans to Regulate Far More AI Tools as Devices. The Industry Won’t Go Down Without a Fight”2 minute read
- Direct Access Laboratory Testing: Navigating the Regulatory Landscape
- Media CoverageBradley Merrill Thompson Discusses FDA Regulatory Hurdles for Breakthrough Devices2 minute read
- Media CoverageBradley Merrill Thompson and the CDS Coalition Request FDA Rescind Final Decision Support Guidance2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Why Congress Quietly Just Gave the FDA More Power”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Industry Group Petitions FDA to Withdraw CDS Guidance”5 minute read
- Unpacking FDA's Final Clinical Decision Support Guidance
- Media CoverageBradley Merrill Thompson Quoted in “Trade Group Pushes Back on FDA’s Clinical Decision Support Guidance”3 minute read
- PublicationsFDA Significantly Reforms Cosmetics Regulations for First Time in Over 80 Years11 minute read
- Post-Dobbs: Considerations for Clinical Trials and Research
- PublicationsCongress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs14 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in “And Over at FDA …”2 minute read
- EventsFrom Roe to Dobbs: Reviewing Changes to Reproductive Health Care Operations and Forecasting What’s Next2 minute read
- PublicationsFTC’s Revisions to Dietary Supplement Advertising Guidelines: More of the Same2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Outlook 2023: The Regulatory Path Ahead”2 minute read
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
- Media CoverageBradley Merrill Thompson Discusses “The Impact of Clinical Decision Support Software on the Healthcare Industry”2 minute read
- EventsINCBA Cannabis Law Sessions at MJBizCon: Mock Negotiation—Buying/Selling a License1 minute read
- Media CoverageOffice Snapshot: Epstein Becker Green's New Nashville Outpost3 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2023 PromotionsOctober 28, 20225 minute read
- EventsNJSBA: Latest Developments in Cannabis Law1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Torres Says Regulatory Alignment a Pressing Consideration for AI Change Control Draft”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software to Predict Risk of Sepsis, Stroke Should Be Regulated as a Medical Device, Says FDA”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA’s Tweak of Mobile Medical Apps Guidance Introduces Transparency Requirement”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Acknowledges Shortcomings of Pre-Cert Pilot in Report”6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Lays Out CDS Stance”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Legal Expert: FDA’s CDS Software Guidance Is a ‘Disaster’ for Industry”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Finalizes Guidance on How Clinical Decision Support Software Is Regulated”2 minute read
- Media CoverageBradley Merrill Thompson Featured in BioWorld: Discussion of FDA Guidance for CDS Software1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Guidance Hikes Oversight of Clinical Decision Support Software”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “A ‘Disaster,’ or a ‘Clear Path’ Forward?: New FDA Guidance on AI in Medicine Sparks Strong Reactions”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Talks Takeaways from Software Precert Pilot”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA’s Pre-Cert Pilot for SaMD Falters Over Lack of Statutory Authority”2 minute read
- Firm AnnouncementsEpstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law2 minute read
- PublicationsOHRP Draft Guidance on the Use of Single IRBs: Reminder to Comment by August 308 minute read
- EventsTech Briefs: Artificial Intelligence and Machine Learning—Making Medical Devices SmarterAugust 25, 20222 minute read
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program”2 minute read
- Media CoverageBradley Merrill Thompson Featured in “Meet the Top 8 Lawyers Helping Startups Patent Artificial Intelligence and Comply with Rules on Privacy and Safety”2 minute read
- PublicationsFDA Greenlights Pharmacists to Prescribe COVID-19 Drug Paxlovid13 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Senate HELP Sends User Fee Reauthorization Bill to Floor Vote”2 minute read
- EventsFDLI: Legal and Regulatory Opportunities to Address Bias and Transparency in Artificial Intelligence/Machine Learning in Medical DevicesJune 14, 20221 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Should Step In to Help Spur AI/ML Standards”3 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2022 Southern California Rising Stars List5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Ends Pre-Cert but Could Revisit in the Future, with Congress’ Help”2 minute read
- Firm AnnouncementsThirteen Attorneys Named to the 2022 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
- Firm AnnouncementsEpstein Becker Green Again Recognized as One of the Largest Health Care Law Firms2 minute read
- Entrepreneurship in Biotech: Growing Your Business
- PublicationsDeconstructing Genus Medical Technologies, LLC v. FDA: A Misunderstood Court Decision16 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Racial Equity Increasing in Device Trials, but Reporting Remains Low”2 minute read
- EventsAmerican University Business Law Review Spring Symposium: Developing Safeguards for AI Caused Gender Bias in Business1 minute read
- EventsMicrofluidics to Address Pandemics - SARS-CoV-2 and Beyond2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “3 Key FDA Topics for Medtechs in 2022”4 minute read
- PublicationsPrescription Digital Therapeutics Don't Need a Physician3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Top Med-Tech Trends of 2021: Regulatory Torpor Adding Drag to Advances in Artificial Intelligence, Machine Learning”6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Biden Nominates Robert Califf to Return as FDA Head”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Issues Long-Awaited Draft Software Guidance in Overhaul of 16-Year-Old Policy”4 minute read
- Firm AnnouncementsEpstein Becker Green’s Commitment to Focused Excellence in Core Practices Extolled in 2022 U.S. News – Best Lawyers “Best Law Firms” Survey5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Clinical Decision Support Guidance Tops FDA’s Agenda for 2022”2 minute read
- Media CoverageEpstein Becker Green Insight on CMS Proposal to Repeal Medicare Coverage of Breakthrough Devices Featured in Orthopedics This Week3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA's 2022 A-List Guidance Plan Hits on Software, Post-Pandemic Future”4 minute read
- Is the Dietary Supplement Regulatory Framework Working?
- Media CoverageBradley Merrill Thompson Quoted in “FDA Resists Industry Push to Nix De Novo Inspections in Final Rule”2 minute read
- EventsThe Year in Review: Food and Dietary Supplement Industry Trends, Key Court Decisions, and Litigation DevelopmentsSeptember 28, 20211 minute read
- Media CoverageBradley Merrill Thompson Quoted in “UK Seeks Overhaul of AI, Software as a Medical Device Regs”3 minute read
- EventsArtificial Intelligence: Bias and Explainability in Algorithms2 minute read
- Firm AnnouncementsFifty-Eight Epstein Becker Green Attorneys Recognized for Professional Excellence–Three Attorneys Distinguished as “Lawyer of the Year”–by The Best Lawyers in America 20227 minute read
- Firm AnnouncementsThirty-Five Epstein Becker Green Attorneys Recognized as “Ones to Watch” by The Best Lawyers in America 20225 minute read
- Media CoverageJames Boiani Quoted in “FDA Class I Medical Device Recalls on Track to Break Record in 2021”3 minute read
- EventsFDLI: Machine Learning for Regulatory Attorneys and English Majors1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Google Launches a New Medical App—Outside the US”5 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Need Mental Health Help? There Are Apps for That, but Picking the Right One Is Tough”6 minute read
- EventsRAPS: US Regulation of Advertising, Promotion, and Labeling for Medical Devices2 minute read
- Firm AnnouncementsFour Epstein Becker Green Attorneys Named to 2021 Southern California Rising Stars List6 minute read
- Federal and State Cannabis Rules Are Moving in Different Directions
- EventsFDLI Annual Conference: Machine Learning for Regulatory Attorneys and English Majors1 minute read
- Media CoverageEpstein Becker Green Becomes Boston Bar Association Sponsor2 minute read
- EventsUS Healthcare Market Playbook: The Effective and Efficient Reimbursement Strategy1 minute read
- Firm AnnouncementsTen Epstein Becker Green Attorneys Named to 2021 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
- EventsOnline Pharmacy Prescriptions and Cyber Security Best Practices2 minute read
- Firm AnnouncementsModern Healthcare Ranks Epstein Becker Green as One of the Nation’s Largest Health Care Law Firms2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Regulation of AI Complicated by Hospital’s Use of In-House Algorithms”4 minute read
- Media CoverageJack Wenik Quoted in “Industry Expects Dietary Supplement Regulation to Increase Under Biden”2 minute read
- EventsFDLI Food and Dietary Supplement Safety and Regulation Conference: Dietary Supplements – Regulatory Challenges and Litigation Risks1 minute read
- President Biden’s Use of the Defense Production Act
- EventsBias in Artificial Intelligence: Legal Risks and Solutions3 minute read
- EventsDiagnosing Health Care: A Discussion of the Biden Administration's First 100 Days in Office1 minute read
- Media CoverageJames Boiani Quoted in “Regulatory Attorney Says Warning Letters Likely to Spike Under New FDA Administration”3 minute read
- The Biden Administration's First 100 Days
- Media CoverageBradley Merrill Thompson Quoted in “FDA Action Plan Puts Focus on AI-Enabled Software as Medical Device”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Promises a Draft Guidance for Change Control for Artificial Intelligence in 2021”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Finalizes Speedier Medical Device Pathway Alternative to Breakthrough Status”3 minute read
- PublicationsCommentary: Digital Health Companies Should Stay Away from FDA in 20212 minute read
- Media CoverageDelia Deschaine, Nathaniel Glasser Featured in Q&A on Cannabis Law5 minute read
- EventsFDLI Enforcement, Litigation, and Compliance Conference: FTC and SEC Litigation, Enforcement, and Application to FDA Authorities1 minute read
- Events2020 Advancing Ethical Research Conference: Complex Conflict of Interest - Understanding the COI Landscape2 minute read
- EventsVirtual Engineering Week: FDA & Medical Artificial Intelligence - What You Need to Know1 minute read
- EventsGCMI Virtual Experiential Learning Program: Reimbursement Pathways1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Prescription Pulse: Experts Split on HHS Sunset Rule”2 minute read
- Firm AnnouncementsEpstein Becker Green’s Focused Excellence in Core Practices Lauded by 2021 U.S. News – Best Lawyers “Best Law Firms” Survey4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AdvaMed Seeks Regulatory Clarity on FDA’s New Digital Health Center”2 minute read
- Media CoveragePhilo Hall Quoted in “In Healthcare, Plenty of Political Action Happens at the State Level”3 minute read
- Firm AnnouncementsDavid S. Poppick, Peter M. Stein Named to 2020 Connecticut Super Lawyers List, Marylana Saadeh Helou Named to 2020 Massachusetts Rising Stars List7 minute read
- Key Considerations for Reshoring U.S. Drug Manufacturing
- Media CoverageBradley Merrill Thompson Featured in MobiHealthNews HIMSSCast: “Is the FDA Taking Digital Health Regulation in the Right Direction?”2 minute read
- Media CoverageEpstein Becker Green’s Latest Health Hires in Boston Featured in Law3602 minute read
- Product Launching in the Era of COVID-19
- Media CoverageBradley Merrill Thompson Quoted in “FDA Establishes Digital Health Center of Excellence”4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Device Experts Say FDA Is Too Heavily Invested in Pre-Cert Program”4 minute read
- PublicationsEpstein Becker Green’s Boston Health Care and Life Sciences Practice Featured in “Hire Up: This Week’s Lateral Market”2 minute read
- Firm AnnouncementsEpstein Becker Green Adds Group of Health Care & Life Sciences Attorneys in Boston6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Touts Lessons from Pre-Cert, Though Next Steps Murky”3 minute read
- EventsRAPS Convergence 2020: Software as Medical Device - Has AI Learned Too Much?2 minute read
- PublicationsBusinesses Beware: FTC Seeks to Codify “Made in USA” Enforcement Policy4 minute read
- Media CoverageDelia Deschaine, Megan Robertson’s Thought Leadership on Cannabis Regulation Featured in Higher Law: “What’s Next: CBD, the FDA, and the White House”3 minute read
- PublicationsCMS Proposes to Expand the Scope of Medicare Coverage Determinations9 minute read
- Holding Pattern: Cannabis Industry Waits for FDA Regulatory Rulemaking
- Media CoverageJames Boiani Quoted in “Virus Testing Push Leaves FDA Lab Oversight in ‘a Bizarre Limbo’”3 minute read
- Media CoverageJames Boiani Quoted in “Botched Covid Plasma Announcement Clouds FDA’s Vaccine Process”1 minute read
- Firm AnnouncementsTwenty-Six Epstein Becker Green Attorneys Recognized as “Ones to Watch” by The Best Lawyers in America 20214 minute read
- Firm AnnouncementsFifty-Five Epstein Becker Green Attorneys Recognized for Professional Excellence–Two Attorneys Distinguished as “Lawyer of the Year”–by The Best Lawyers in America 20217 minute read
- PublicationsStates Are Questioning Medicaid MCO Rx Benefits3 minute read
- EventsZeroTo510: Reimbursement – Medical Device Accelerator1 minute read
- PublicationsU.S. Department of Justice’s Pandemic-Related Enforcement Priorities Warrant Caution by Businesses16 minute read
- PublicationsPostmarket Responsibilities for Medical AI: Part III — FDA Should Not Expand Its Oversight of Commercialized AI3 minute read
- Firm AnnouncementsEpstein Becker Green Ranks Highly as One of the Largest Health Care Law Firms by Modern Healthcare2 minute read
- PublicationsPostmarket Responsibilities for Medical AI: Part II — What Industry Should Do in Commercializing Medical AI2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Makers Want FDA to Preview Post-Pandemic Flexibility Plans"3 minute read
- PublicationsPost-Market Responsibilities for Medical AI: Part I – FDA's Plan to Increase Its Oversight3 minute read
- Firm AnnouncementsFive Epstein Becker Green Attorneys Named to 2020 Southern California Rising Stars List6 minute read
- EventsFDA Registration for Digital Health – AI2 minute read
- Media CoverageJames Boiani Quoted in "Psychedelic Meds Are Opening a New Frontier for Legal Work"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Offers Psychiatric Device Flexibility, Expands 'Wellness' Definition"5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "How FDA Is Backing the Use of Artificial Intelligence in Telemedicine"2 minute read
- PublicationsFDA's Support of AI in Telemedicine2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Akili's Digital Therapeutic Launches Early for Housebound Children with ADHD"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Eases Guidelines for New mHealth, Telemental Health Treatments"3 minute read
- Firm AnnouncementsSixteen Epstein Becker Green Attorneys Named to 2020 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA: Devs Can Release Digital Products for Psychiatric Disorders Without 510(k) Submission During COVID-19 Crisis"3 minute read
- Media CoverageJames Boiani Quoted in "Startups Spar with FDA Over What Constitutes a Home Coronavirus Test"3 minute read
- PublicationsNew Developments in FDA Regulation of AI2 minute read
- EventsFDA CDS Software Regulation: The Latest Guidance on Clinical Decision Support Software2 minute read
- PublicationsThe CARES Act: Key Provisions for Health Care Providers7 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Gives Guidance on 'Coronavirus’ Thermal Fever Detection Systems"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Digital Health Advice from FDA Amid Coronavirus Leaves More Questions Than Answers"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Still Trying to Fine-Tune Pre-Cert as Pilot Enters 2020"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Issues Emergency Guidance for Non-Invasive Remote Monitoring Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Steps on Gas for Digital Health"2 minute read
- EventsAPhA2020: The Drug Cost Controversy, Part 2 – What's Next?1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Expands Use of Vital Sign Monitors to Enable Remote Care, Modifications During COVID-19 Emergency"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Greenlights Expanded Remote Patient Monitoring to Keep Patients Out of Coronavirus-Slammed Hospitals"3 minute read
- PublicationsOIG Permits Manufacturer of Personalized Medicine Drug to Cover Patients' Travel, Lodging, and Other Expenses9 minute read
- PublicationsDSCSA Delays Raise Doubts2 minute read
- Media CoverageStuart Gerson Quoted in "Outlook 2020: Integrity Rule, Inpatient Audits Will Stir Things Up; Privacy Is 'Huge Focus'"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Latest FDA Clinical Decision Support Software Draft a Step Forward, Industry Says"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Stakeholders See More Holes in FDA's Revised CDS Draft Guidance"3 minute read
- Media CoverageBradley Merrill Thompson Cited in "A Closer Look at the FDA's Moves, Clearances in the Second Half of 2019"3 minute read
- Media CoverageBradley Merrill Thompson Featured in "Faces of UMSI" – a Michigan Law Grad Who Decided to Go Blue Again, Three Decades Later4 minute read
- EventsPATH Summit 2019: New Public Policy Developments Affecting PATH Members1 minute read
- EventsFood and Drug Law Institute 2019: Enforcement, Litigation, and Compliance Conference - the Current State of Dietary Supplement Enforcement1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Dexcom App Outage Highlights Communication Pitfalls for Device Makers"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Dexcom Talks More About Alerts Outage"2 minute read
- EventsPolitics and Perspectives: Finding a Cure - Strategies for Tackling the High Cost of Prescription Drugs1 minute read
- PublicationsTo Eat or Not to Eat: CBD "Edibles" Receive Mixed Reaction from States and Steady Opposition from FDA2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Special Treatment of Big Tech Faces Mounting Scrutiny"3 minute read
- Firm AnnouncementsEpstein Becker Green Lauded by 2020 U.S. News – Best Lawyers "Best Law Firms" Survey4 minute read
- PublicationsApplying Data Science Principles to FDA's PreCert Program: Some Scary Stuff3 minute read
- Events10th Anniversary CNS Summit: Digital Therapeutics1 minute read
- Publications8 Best Practices for Cannabis Transaction Due Diligence1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "There's a Lot on FDA’s 2020 Guidance Priorities Lists – but the Software Pre-Cert Program Isn't One of Them"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Optimistic About Second CDS Draft Guidance; FDA Releases More Final Software Guidances"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Expert Says FDA's CDS Guide Revision Could Raise Legal Issues"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Puts Out New Decision Support Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Revises Clinical Decision Support Software Draft After Industry Blowback"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Releases Revised Draft Guidance on CDS Software, Final Guidelines on 'Device' Definitions for Software Such as Wellness Apps"3 minute read
- EventsDrug Pricing Transparency Congress: Strategize for 2020 - Breaking Down Transparency Headlines for Industry1 minute read
- PublicationsChapter 6, "Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "How Apple, Fitbit, Samsung and More Are Helping to Modernize the FDA"1 minute read
- Firm AnnouncementsForty-Seven Epstein Becker Green Attorneys Named by The Best Lawyers in America 2020, One Attorney Distinguished as "Lawyer of the Year"5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Combination Product Reporting Rule Set for 2020 Enforcement"2 minute read
- PublicationsINSIGHT: Drug Supply Chain Security Act Projects Create Opportunities, Pose Questions2 minute read
- PublicationsSomewhere Beyond the Sea: The Drug Importation Conundrum2 minute read
- Media CoverageChristopher Smith’s Article on the Drug Supply Chain Security Act Featured in Bloomberg Roundup: "For Your Consideration"2 minute read
- PublicationsINSIGHT: The Drug Supply Chain Security Act and Preemption of State Laws2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lawyer Applauds Combo Products Guide but Says Some Details Missing"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Lawyer: FDA's Pre-Cert Update Seems Promotional, Lacks Answers"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "One Small Step for US FDA, but Maybe a Giant Leap for SaMDs"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Pear Files Insomnia and Depression Software as Pre-Cert Pilot 510(k)"3 minute read
- EventsStartup Roadshow Encore Webinar: AI in Healthcare3 minute read
- EventsNEHI: Next Generation Therapies - What's Next?1 minute read
- Firm AnnouncementsModern Healthcare Recognizes Epstein Becker Green Among Top 10 Largest Health Care Law Firms2 minute read
- EventsUS Regulation of Advertising, Promotion, and Labeling for Medical Devices: Intended Use & Off-Label Promotion1 minute read
- Media CoverageJames Boiani Quoted in "At-Home Tests for Influenza, Strep, Others Raising Eyebrows of Some Experts"2 minute read
- Trends in Cybersecurity of Medical Devices: Thought Leaders in Health Law Video Series
- Media CoverageBradley Merrill Thompson Quoted in "Roche, J&J Regulatory Leads Weigh In on Pre-Cert's Progress, Challenges of Regulating Digital Health"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FitBit, Verily Make Inroads at FDA as It Weighs Software Rules"2 minute read
- Events2019 BIO International Convention: Current and Future Regulatory Environment for Digital Health1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Expert Worries FDA Might Not Get Takers for Pre-Cert Test Plan"2 minute read
- Firm AnnouncementsFive Epstein Becker Green Attorneys in CA and FL Named to 2019 Rising Stars Lists6 minute read
- Firm AnnouncementsEpstein Becker Green Grows Health Care & Life Sciences Practice with New Hires4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Moving on Pre-Cert Test Plan Despite Questions About Authority"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks Software Developer Test Cases for Precertification Program"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Call for Volunteers"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Testing the Limits: Software De Novo, 510(k) Volunteers Wanted By US FDA"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Wants New Companies to Help Test Its Pre-Cert Program"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Soliciting New Volunteers to Test Drive Its Experimental Pre-Cert Program"2 minute read
- Media CoverageBradley Merrill Thompson Featured in "An Illini Lineage: The Thompson Family's Relationship with Illinois Goes Back Almost a Century"3 minute read
- Trends and Legal Risks in Medical Marijuana: Thought Leaders in Health Law Video Series
- Media CoverageBradley Merrill Thompson Quoted in "Experts Raise Concerns with FDA Draft Guidance on Combo Product Reviews"2 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- Media CoverageRobert Wanerman Quoted in "CMS Floats New Add-On Payment Route for Breakthrough Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Extends Postmarket Reporting Deadline for Combo Products"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Experts Seek Alignment of Standards Recognition Across FDA's CDER, CBER, CDRH"3 minute read
- Media CoverageJames Boiani Quoted in "What's Next for the Post-Gottlieb FDA"3 minute read
- Firm AnnouncementsSixteen Epstein Becker Green Attorneys in Washington, DC, Named to 2019 Super Lawyers and Rising Stars Lists6 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- PublicationsCBD Scrutiny May Signal Broader FDA Enforcement Trend3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Unveils Framework for AI-Based Medical Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New AI White Paper"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Takes First Steps Toward New Guidance for Adaptive Medical AI"2 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- EventsFood Enforcement and Compliance Conference: Criminal Enforcement1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA: Device Center’s Total-Life-Cycle Reorganization to Begin March 18"3 minute read
- PublicationsCommentary: FDA's Website Has Wrong Information About the Scope of Its Software Regulation — And That's a Big Problem2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Experts Question FDA Proposal to Conduct Manufacturing Inspections for De Novo Reviews"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "What Does Gottlieb's Resignation Mean for Medtech?"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Gottlieb, Whose FDA Made Major Strides in Digital Health, Resigns as Commissioner"2 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- PublicationsFDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Officials: Too Soon to Answer Device Industry Pre-Cert Questions"3 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- EventsPropel Medical Device Executive Webinar Series: Are Your Products Ready for the FDA’s New Digital Health Pre-Cert Program?1 minute read
- PublicationsHow Many Companies Stand to Benefit from the FDA Pre-Cert Program? Fewer Than You Might Think2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Combo Products Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA’s New Draft Guidance Could Hinder Applications for Digital Combination Products"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "510(k) Modernization: FDA Floats Need to Pursue New Authority"2 minute read
- EventsStartup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare4 minute read
- Media CoverageBradley Merrill Thompson Featured in "Quoted," on the FDA’s Digital Health Pre-Certification Program1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Regulatory Uncertainty Persists Around Medical Software"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Pre-Cert Program Will Start Off Slow with De Novo Framing, but Big Questions Remain"4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Experts Disagree Over Whether FDA Has Authority for PreCert"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Looks to De Novo Pathway Model as it Unveils Updates to Pre-Cert Program"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Targets De Novo Path to Shepherd Medical Software Through Pre-Cert"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Will Telehealth and mHealth Fulfill Their Potential in 2019?"5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lawyers: FDA Proposed De Novo Rule Might Discourage Developers"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lawyer: FDA Digital Health Report Reassuring, But Short on Safety Tips"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "US FDA Medical Software Report Rests Concerns of Increased Regulation"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "An FDA Age-Based Predicate Policy Would Be Arbitrary, Reg Experts Complain"3 minute read
- Media CoverageMegan Robertson, Lauren Farruggia Featured for FDLI Presentation on FDA Software Regulation2 minute read
- Media CoverageJames Boiani Quoted in "Lawyers: FDA's CLIA Waiver Guidances Give Industry More Flexibility"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Apple Now Says Its Smartwatch Tech to Detect Atrial Fibrillation Is Not for Those with Atrial Fibrillation"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's De Novo Pathway Is About to Get a Makeover"2 minute read
- PublicationsThe Criminalization of Dietary Supplement Enforcement3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Lawyer: 510(k) Plan Violates Statute, FDA 'Too Big for Britches'"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Experts Question Impact on Innovation, FDA Authority to Pursue Revamp of 510(k) Pathway"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Looks to Restrict Older Predicate Devices, Introduce New Regulatory Pathway"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Considering Imposing 10-Year Limit When Manufacturers Choose Older Predicates"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks $46M to Fund National Evaluation System for Health Technology"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Rolls Out New Rx-Use-App Paper"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Roundup: 12 Healthcare Algorithms Cleared by the FDA"2 minute read
- EventsDiabetes Technology Meeting: The FDA Pre-Certification Program for Software as a Medical Device1 minute read
- PublicationsDiabetes Technology Society Report on the FDA Digital Health Software Precertification Program Meeting2 minute read
- Firm AnnouncementsEpstein Becker Green Is Recognized in the 2019 U.S. News – Best Lawyers “Best Law Firms” Survey4 minute read
- Media CoverageAlaap Shah Quoted in "FDA Cyber Guide Provides Key Testing, Documentation Updates"3 minute read
- EventsFDA Medical Device Recalls: Now and Then4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Top Democrats Question FDA Pre-Cert Program Safety, Statutory Authority"2 minute read
- Media CoverageStuart Gerson Quoted in "Kavanaugh to Play Role in Drug Patent, Pharmaceutical Company Liability Cases"2 minute read
- Media CoverageStuart Gerson Quoted in "Drug, Device Lobbies Weigh In on Utah Device Liability Case"1 minute read
- EventsFood and Drug Law Institute: Developments in FDA Software Regulation1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate Democrats Raise Major Concerns October 11, with FDA Software Pre-Cert Plan"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Elizabeth Warren, Colleagues Pen Critical Letter on FDA Pre-Cert"2 minute read
- EventsU.S. Healthcare Compliance Certification Program1 minute read
- EventsPATH Summit: Legal and Policy Issues Surrounding the Use of Advanced Technologies to Provide Healthcare Services1 minute read
- EventsPATH Summit: Partnership for Artificial Intelligence and Automation in Healthcare1 minute read
- Media CoverageRobert Wanerman Quoted in "Trump Might Pay for Some Devices Before Medicare Approval: Industry"3 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Approval of Apple Watch ECG Monitoring Capability6 minute read
- PublicationsFDA's Dramatic Announcement of Apple's Clearances: Is There a Level Playing Field at FDA?2 minute read
- PublicationsCommentary: Why FDA's Software Precertification Program May Be Bad for Business2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Lawyer Says FDA-Proposed Device Accessory List Too Short"2 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Selected for The Best Lawyers in America 2019 and Four Attorneys Named "Lawyer of the Year"5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "US FDA's Software Pre-Cert Program: Is the Authority on the Books?"3 minute read
- PublicationsCDRH’s New Post-Market Paradigm: Why the Public Should Be Worried3 minute read
- PublicationsNew Gene Therapy Guidances Signal Anticipated Growth of Product Submissions by FDA11 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Balks at FDA's Cybersecurity Plans"2 minute read
- EventsDigital Health Tools: What YOU Need to Know - Prepare Now for the FDA's Transformative Project1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Lawyer: Pre-Cert Program Exceeds Statute, Issues Unresolved"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Second Draft Pre-Cert Released but Real Rule-Making Needed"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDRH Faces Tight Deadline as Questions Raised on Pre-Cert Pilot Design"2 minute read
- Media CoverageBradley Merrill Thompson Comments on the FDA's Pre-Certification Program Working Model2 minute read
- Media CoverageJames Boiani Quoted in "The Ins and Outs of Lab-Developed Tests"4 minute read
- Media CoverageStuart Gerson Quoted in "Lawyer Close to Kavanaugh Said He Avoids Knee-Jerk Deference to FDA"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Heads Call for Flexible Regulatory Framework for Medical Software"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Green-Lights 14 Digital Health Products, Continues to Evolve Regulations"2 minute read
- Media CoverageJames Boiani Quoted in "Device Lawyer: FDA Guidances Provide Clarity on Payer Communication"2 minute read
- Media CoverageBradley Merrill Thompson Featured in "Regulating CDS and AI: Which Way Forward?"2 minute read
- PublicationsCheers to 80 Years of the Food, Drug, and Cosmetic Act1 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Pre-Certification Update in Multiple Publications4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Releases Draft Patient-Experience Data Guidance"2 minute read
- EventsTOBI 2018: FDA Guidelines for Regenerative Cellular Therapies, Including Autologous Procedures1 minute read
- Media CoverageAmy Dow Quoted in "Right to Try Pros and Cons"2 minute read
- Media CoverageAmy Dow Quoted in "Congress Gives Patients the 'Right to Try' Experimental Drugs, Bill Heads to White House"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Attorney: FDA Draft Re-Do of Part 3 Eases Agency's Legal Burden"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Proposes Changes to Classification Rules for Combo Products"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Unveils Working Model for Software Precertification Program"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Lays Out Next Steps for Pre Cert Pilot"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Readies Digital Health Pre-Cert Program for Lift Off"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Attorney Says FDA's New Device Plan Oversteps Authority"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Gottlieb Unveils Digital Health Tools for Drug Development, Pre-Cert Model"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "As FDA's Pre-Cert Plan Takes Shape, Worries Emerge About Overreach"2 minute read
- Firm AnnouncementsSeventeen Epstein Becker Green Attorneys Named to 2018 Washington DC Super Lawyers and Rising Stars Lists5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "The Fourth Wave: Digital Health Newsletter for Apr 13"2 minute read
- Media CoverageJames Boiani Quoted in "FDA Wants to Ease Diagnostic/Drug Combo Study Paperwork"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Permits Marketing of AI Software That Autonomously Detects Diabetic Retinopathy"2 minute read
- EventsFDLI: Introduction to US Medical Device Law and Regulation - Overview of Medical Device Law and Regulation Organizational Structures1 minute read
- PublicationsFDA Reneged on Its Promise to Take a Risk-Based Approach to CDS Software1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Digital Health Program Not Broad Enough, Industry Says"2 minute read
- Media CoverageJames Boiani Quoted in "Nicotine Replacement Trials and the App Effect"3 minute read
- Media CoverageJack Wenik Quoted in “Panel: HR Departments Must Do More to Assist Opioid-Addicted Employees”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Why the FDA's Recent Glucose Monitoring System Approval Matters for Interoperability"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CMS Under Pressure to Cover mHealth Tools for Diabetes Management"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Approves Interoperable Continuous Glucose Monitoring System"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Combination Products: US FDA Extends Safety-Reporting Deadline"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Delays Combination Product Safety Reporting Requirements"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Streamlines Safety Reporting for Drug-Device Combos"3 minute read
- EventsCHPA 2018 Annual Executive Conference: The Changing Consumer Health IT Regulatory Environment1 minute read
- PublicationsFDA Extends Regulatory Reach to Low-Risk CDS Software2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Approves AI Stroke Application, Signaling a Shift in Triage Software Oversight"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Viz.ai's Stroke-Detecting CDS App Receives FDA Nod"2 minute read
- Media CoverageJames Boiani Quoted in "What Hospitals Need To Know Before Forming A Drug Co."2 minute read
- Media CoverageBradley Merrill Thompson and CDS Coalition Discuss the FDA’s Draft Guidance on Clinical Decision Support4 minute read
- Media CoverageAmy Dow Quoted in "Compassionate Use: A Look into Goldwater Institute v. HHSand 'Right to Try' Legislation"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's First Pre-Cert Workshops Give Industry and Agency a Chance to Talk"3 minute read
- EventsThe Food and Drug Administration's Approach to Evaluating Nicotine Replacement Therapies: Public Hearing1 minute read
- Firm AnnouncementsEpstein Becker Green Named a 2017 "Health Practice Group of the Year" by Law3602 minute read
- EventsDigitalHealth.il: FDA's Approach to AI in Healthcare - New Wine in an Old Wineskin1 minute read
- Media CoverageJames Boiani Quoted in "Labs Hopeful for Less Severe Penalties for Referral Mishaps"2 minute read
- Media Coverage"FDA Guidance on Decision Support Software: Implications for Industry" Featured in POLITICO Morning eHealth2 minute read
- PublicationsFDA Guidance on Decision Support Software: Implications for Industry5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Outlook 2018: Pharma/Life Sciences Law and Policy"2 minute read
- Media CoverageJames Boiani Quoted in "Life Sciences Regulation to Watch in 2018"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Medical Device Experts Criticize FDA's Clinical Decision Support Draft Guide"2 minute read
- Media CoverageJack Wenik's Presentation on Dietary Supplement Litigation Featured in Natural Products INSIDER2 minute read
- Trends in Precision Medicine: Thought Leaders in Health Law Video Series
- PublicationsThe Dietary Supplement Industry in the Time of Trump: Potential Opportunities and Pitfalls2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Aims to Ease Medical Device Approval Burdens"2 minute read
- Media CoverageBradley Merrill Thompson Discusses the FDA's Long Anticipated New Guidance on Digital Health Devices and Clinical Decision Support Guidelines5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Who Is Liable for Faulty Artificial Intelligence in Health Care?"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks to Speed Approvals of Generic Drug-Device Combos"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Approves First Drug with Digital Ingestion Tracking System"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health-Care Cybersecurity Takes Center Stage"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Grading Gottlieb: How Attys View FDA Chief's First 6 Months"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health Privacy Official's Departure Unlikely to Rock the Boat"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Announces New Market Pathway for Genetic Health Risk Tests"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Some Genetic Tests Will Get Quicker FDA Path to Market"2 minute read
- PublicationsThe "New" NDC: Are You Aware of FDA's Rollout of the New Unique Medical Device Identifier (UDI) and Its Potential Future Impact on Payer Claims Forms?2 minute read
- Firm AnnouncementsEpstein Becker Green Is Recognized in the 2018 U.S. News – Best Lawyers "Best Law Firms" Survey3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Gives Advice on Getting Innovative Devices to Market Faster"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Makers Get FDA Guidance on Premarket Clearances"3 minute read
- PublicationsFive Regulatory Myths Keeping Bio/Pharma Out of Digital Health2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Clarifies When to Submit 510(K) for a Software Change"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Finalizes Guidance on Software Modifications"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Finalizes New Guidance to Support Medical Device Innovation and Ease Burden of Software Updates"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New FDA Guidances Aim to Increase Clarity on When Developers Need to Resubmit 510(K)s"3 minute read
- Media CoverageJames Boiani Quoted in "FDA Final Guidance on Drug/Device Classifications Misses the Mark, Attorneys Say"2 minute read
- PublicationsBradley Merrill Thompson Quoted in "The New Mobile Age: How Technology Will Extend the Healthspan and Optimize the Lifespan"1 minute read
- Media CoverageJames Boiani Featured in "FDA Challenges Abuse-Deterrent Opioid Drug Claim"2 minute read
- EventsAHLA: The Opioid Crisis - New Government Enforcement Initiatives and Future Implications for the Healthcare Industry1 minute read
- Trends in Enforcement of Dietary Supplements: Thought Leaders in Health Law Video Series
- Media CoverageBradley Merrill Thompson Quoted in "Apple Watch: Fast-Tracking Medical Tech with Its Heart Rate Monitor"2 minute read
- PublicationsWhy New Guidelines Are the Best Way to Address Medium-Risk CDS Software2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "We Now Know That Apple, Alphabet and Samsung Are Making Long-Term Bets on Health Care"2 minute read
- EventsFDLI Advertising and Promotion Conference: Risk Information in Direct-to-Consumer Broadcast Advertisements for Prescription Drugs1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks Input on How to Review Certain Device, Drug Combos"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Apple and Fitbit Among the 9 Companies Selected for FDA's Coveted Digital Health Pilot"2 minute read
- EventsSupplySide West: FDA Lawsuits and Class Action Litigation in the Dietary Supplement Industry1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Analysis: 2 Barriers to Apple's Smartwatch, Arrhythmia Detection Project"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Don't Wait for the Apple Watch to Dole Out Medical Advice Anytime Soon"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Why the Apple Watch Won't Replace Your Doctor Anytime Soon"2 minute read
- EventsNJHA and NJSBA Annual Joint Meeting: Focus on the Opioid Epidemic - Enforcement and Prevention1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Federal Agency Guidance: An Institutional Perspective"2 minute read
- EventsMedical Device Usability and Human Factors Engineering Conference: FDA Oversight of Human Factors Engineering for Combination Products1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA to Drug/Device Combo Makers: Wait for Reporting Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Apple Watch to Act as Heart Monitor"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Ignores Advamed Requests in Final RWE Device Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Coalition Issues Final Guidelines on CDS Software Design"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA to Hire Entrepreneurs-in-Residence to Help Develop PreCert Software Program"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "September Eyes Turn to CHIP Funding"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Medical Software Industry Issues Guidance to Keep FDA at Bay"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Government Urged to Avoid Burdening Health-Data Exchange Users"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Coalition Finalizes Clinical Decision Support Guidelines Aimed at Self-Regulation"2 minute read
- Media CoverageBradley Merrill Thompson, Kim Tyrrell-Knott Featured in "CDS Coalition Drops Voluntary Guidelines for Unregulated Clinical Decision Support Software"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDS Coalition Releases Guidelines in Self-Regulatory Effort"2 minute read
- PublicationsCoalition Finalizes Guidelines for the Design of Medium Risk Clinical Decision Support Software2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Watchers: Gottlieb May Fly Under Trump Deregulatory Radar with Product-Specific Moves"2 minute read
- EventsSpecialty Pharma Association Regulatory Workshop: Pharmacovigilance Agreements1 minute read
- PublicationsLearning from Experience: FDA's Treatment of Machine Learning2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Gottlieb Issues Fewer Guidances and Delays Some Key Rules, But Hasn't Chopped Any Yet"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Stakeholders Praise Gottlieb for Keeping the Agency on Track"2 minute read
- Firm Announcements38 Epstein Becker Green Attorneys Selected for The Best Lawyers in America 2018, One Honored as "Lawyer of the Year"5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Appears to Answer AdvaMed Concerns Over Device Tool Program"3 minute read
- PublicationsPrivacy Implications for Biotechnology2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Federal Advisers Likely to Push for Better Health Data Exchange"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "9 Companies Will Play a Huge Role in Shaping the FDA's Novel Approach to Digital Health"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Defeat for Obamacare Repeal in the Senate"1 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Announcement of Digital Health Innovation Action Plan and Launch of Pre-Cert Pilot Program4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Rx, Device Groups Tell FDA to Scrap Latest Off-Label Rule"2 minute read
- EventsWebinar on What Investors and Startups Need to Know About Using Machine Learning in Clinical Decision Support Software and the Scope of FDA Regulation2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Innovation Initiative to Modernize the FDA"2 minute read
- PublicationsResponse: First Birth Following Spindle Cell Transfer2 minute read
- Media CoverageJames Boiani Quoted in "Combo Product Appeals Low in Number, but Lengthy in Decision Time"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Pharma Raises Stakes in Digital Health"1 minute read
- Media CoverageMark Lutes Featured in MCOL ThoughtLeaders: Outcomes-Based Pricing Arrangements3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Says It Will Clarify Digital Health Regulations"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Bayer Gets FDA Nod for App-Connected Injector for MS Patients"2 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA Commissioner's New Plan for Mobile App Regulation4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "US FDA's New Game Plan for Digital Health"3 minute read
- Media CoverageStuart Gerson Quoted in "Fallout from OIG Report May Be Light"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "One In, Two Out Executive Order Will Likely Increase Use of Internal FDA Communications"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Will a New FDA User Fee Discourage Medical Device Innovation?"3 minute read
- Media CoverageConstance Wilkinson Quoted in "Top Four Approaches to Reduce Pharmaceutical Costs"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cyber on Stage"1 minute read
- PublicationsDeregulation Helps Pharma Companies Pursue Digital Health Strategies1 minute read
- EventsCombination Products Regulation, Policy & Best Practices: Combination Products - Perspective of the Combination Products Coalition1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Questions Ahead for VA-Cerner Marriage"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Reject Off-Label Drug, Device Promotion Bills, Groups Tell Lawmakers"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "How Should Digital Health Vendors Interpret New York’s Move to Flex Its Regulatory Muscle?"1 minute read
- PublicationsHow the FDA Could Impact Machine Learning, IoT in Healthcare2 minute read
- Media CoverageJames Boiani Quoted in "FDA Takes Steps Toward Creating Lab Accreditation System for Evaluating Medical Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate User Fee Bill Sets Up New Path to Reclassify Device Accessories"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA to Create Centralized Digital Health Unit"2 minute read
- Media CoverageStuart Gerson, Bradley Merrill Thompson Quoted in "Bipartisan House Bills Take Aim at Unsafe Medical Devices"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDS Coalition Floats Guidelines for Mobile Health App Design"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New Clinical Decision Support Software Guidelines Highlight Keys to Self-Regulation"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Drug, Device Industries Seek Fewer Limits on Off-Label Communications"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Legislation Would Streamline Risk-Classification for Device Accessories"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Bipartisan House Bill Would Ease Device-Accessory Reviews"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Congress Chugging Along"2 minute read
- Firm AnnouncementsSixteen Epstein Becker Green Attorneys Named to 2017 Washington DC Super Lawyers and Rising Stars Lists5 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDS Tools Fall Short in Meeting Physicians' Needs in Care Delivery"2 minute read
- PublicationsTrump, Gottlieb, and the Cures Act: What Pharmaceutical Manufacturers Need to Know15 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Loosens Controls on Some Low-Risk Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "NY AG Puts Mobile Health App Makers on Notice That FDA, FTC Not Only Enforcers of Health Claims"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Wellness Apps Evade the FDA, Only to Land in Court"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Arizona Law Puts Pressure on FDA to Change Off-Label Policies"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "NY Attorney General Takes on Mobile Health App Makers"2 minute read
- PublicationsWhy Has Model-Informed Precision Dosing Not Yet Become Common Clinical Reality? Lessons from the Past and a Roadmap for the Future2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New York Taps Away Misleading Health Info for Smartphone Users"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health Tech Oversight Up in the Air in Wake of New HHS Position"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "New York Attorney General Settles with Three Mobile Health Apps"2 minute read
- Media CoverageJames Boiani Quoted in "Combo Products Won't Get Special Review Pathway at US FDA Anytime Soon"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Trump's Proposal to Increase FDA User Fees Could Impact Small Digital Health Innovators"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Proposal Would Lower Requirements for Some Moderate-Risk Devices"2 minute read
- PublicationsFDA's Next Frontier: Regulating Machine Learning in Clinical Decision Support Software2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "3 Ways Trump's FDA Nominee Could Reshape Digital Health"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Wants HHS Scrutiny of Health Information Technology Office"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Seeking Feedback on New Office of Patient Affairs"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Will Remote Software Updates Become the Norm for Medical Devices?"2 minute read
- Media CoverageJames Boiani Discusses Petitioning FDA on Combo Drug Appeals Within 60 Days2 minute read
- Media CoverageJames Boiani Quoted in "Law Firm Challenges FDA on Combination Product Appeals"2 minute read
- Media CoverageJames Boiani Quoted in "Combination Product Designations at US FDA Need Faster Appeals, Petition Says"2 minute read
- Events17th Annual Conference on Fraud and Abuse in the Sale and Marketing of Drugs, Devices, and Medical Technology: Regulatory and Legal Considerations When Using Social Media to Promote Drugs and Medical Devices1 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Named to Law360 Editorial Advisory Boards2 minute read
- Media CoverageAmy Dow Featured in "Law360Life Sciences Editorial Advisory Board"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Citizens Petition Challenges FDA's Off-Label Rule"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senators Want to Fix FDA's Inspection Process for Device Companies"2 minute read
- PublicationsSix Key Changes to the Common Rule13 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Big Pharma Objects to New Hurdles for Off-Label Drug, Device Promotion"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Delays Rule Affecting Off-Label Drug, Device Promotion"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Lame Duck Document Dump Prompts Congressional Scrutiny, Industry Sources Mixed"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "The FDA's Proposed Rule on E-Labeling Raises Serious Concerns"2 minute read
- Media CoverageStuart Gerson Quoted in "Gorsuch's Antipathy to Agency Rules May Boggle Health Industry"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Hiring Freeze May Hurt FDA User Fee Programs, Democrats Say"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health IT Fallout from Latest Trump Order"1 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in "Trump's Two-for-One Reg Order Needs Agency Interpretation, Medtech Reg Experts Say"2 minute read
- PublicationsBusiness Strategies for Technology Companies Wanting to Play in the Health Care Internet of Things2 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "FDA Wins Kudos from Industry in Combo Product GMP Final"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Wins Kudos from Industry in Combo Product Good Manufacturing Practice Final"2 minute read
- PublicationsMarketing Strategies for Technology Companies Wanting to Play in the Health Care Internet of Things2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "A Look Ahead at Digital Health and Health Policy Under President Trump"2 minute read
- Media CoverageStuart Gerson Quoted in "Obama's FDA Leaves Mark with Last-Minute Policy Blitz"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Lab Test Oversight Plan Scaled Back Under Revised FDA Proposal"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Clarifies Rule on Tobacco Products in Medical Realm"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Floats New Oversight Plan on Lab Tests"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Drug/Device Combo Makers Have Chance to Weigh in on FDA Policies"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Lays Out Possible Risk-Based Approach to LDT Oversight"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Drug/Device Combo Makers Get Clarity on Manufacturing Requirements"2 minute read
- PublicationsStrategies for Technology Companies Entering the Health Care Internet of Things3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Final Rule Clarifies When Tobacco Products Are Regulated as Drugs, Devices"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Passes the Buck on LDTs, but Floats Ideas"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Provides Accessories Guidance, but May Be 'Missed' Opportunity"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Potential Cures Hiccup Spotted"1 minute read
- Media CoverageJames Boiani Quoted in "Life Sciences Legislation and Regulation to Watch in 2017"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Offers Tech Companies Scant Help in Device Guidance"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "What the FDA Did in Digital Health in 2016"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDRH's Guidance Goals for 2017"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Medical Device Decision Guidance Revised in Response to Criticism"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Praises Combo Product Rule But Still Seeks New Postmarket System"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Clinical Decision Support Software Guidance Kicked Off FDA's Priority List"2 minute read
- Trends in Digital Health: Thought Leaders in Health Law Video Series
- Media CoverageBradley Merrill Thompson Quoted in "Pharma/Device Firms Get Clarity on Safety Reports for Combo Products"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Combo Product Sponsors Convince US FDA to Change Postmarket Reporting Rule"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cures Exempts Some Medical Software; More Clarity Needed, Attorneys Say"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cures Act Adds Tough Penalties for Electronic Information Blocking"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “What a Trump Administration May Mean for Digital Health”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Congress Sends Cures Legislation to President"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Combo Product Safety: US FDA Rule on Post-Market Reporting Nears Finalization"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "21st Century Cures Act Clarifies FDA Regulation of Software"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "'Cures' Bill Circumvents FDA on Medical Software Regs"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cures Bill Could Lift FDA Regulation of Physician Software"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Scoop: Emails Show FDA Asked Apple to Advise on Software as a Medical Device"1 minute read
- Media CoverageJames Boiani Quoted in "What's Next for LDTs? FDA May Be Eyeing a New Game Plan"1 minute read
- Media CoverageJames Boiani Quoted in "Backers of Stricter Lab Test Policies Disappointed with FDA Delay"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cybersecurity Asks: More on FDA"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "What Will a Trump Presidency Mean for Digital Health?"1 minute read
- EventsASPL: 340B Drug Discount Program: Evolving Compliance Standards for Covered Entities and Contract Pharmacies in Wake of Proposed 340B Mega Guidance and Orphan Drug Ruling1 minute read
- Media CoverageJames Boiani Quoted in "Stakeholders: Codevelopment Guide Lacks Clarity on Complementary DX"1 minute read
- Firm AnnouncementsEpstein Becker Green Is Recognized in the 2017 U.S. News – Best Lawyers "Best Law Firms" Survey3 minute read
- Media CoverageBradley Merrill Thompson Featured in "Interview: Putting the Pieces Together for Combo Products Oversight"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks Input on Clinical Evaluation of Software as a Medical Device"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Floats New Draft Guidance, Created by International Group, on Software as a Medical Device"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks Input on Software-As-A-Med Device Regulation"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Next Step in Global Convergence: FDA Looks to Make IMDRF Software Guidance Its Own"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "House Rules Chair Seeks to Limit Agency Use of Guidance Documents"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "International Guidance on Software"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Global Group Offers Guidance on Medical Software"2 minute read
- PublicationsThe FDA's 5-Year Delay on Automated Medicine Must End1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Updates Food Categories in Rare Guidance with 'Binding Effect' "1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Eyes Plan to Lessen Review Burden for Software Updates"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Device Priorities Include Streamlining Clinical Trials"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Dispatch from FDA/CTA Digital Health Tech Expo"2 minute read
- Media CoverageJames Boiani Featured in "US FDA Agrees to CLIA Waiver Process Reforms, but More Is Needed, Coalition Says"2 minute read
- EventsACI's 28th FDA Boot Camp: Navigating the Approval Process for Drugs and Biologics1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks to Prevent Opioid Overdoses Through Its First-Ever Mobile App Challenge"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Group Urges Advisory Opinions for Clinical-Decision Support Products"1 minute read
- Media CoverageJames Boiani Quoted in "FDA Delays UDI Date for Some Devices as It Finishes Convenience Kit Guide"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Special Report: Obama Policy Wind-Up Could Affect Drugmakers, Device Companies"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "CDS Coalition Petitions FDA for Guidance on Drug Treatment Software"1 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "Apple Guidelines Could Help Boost Health App Quality"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software Coalition to FDA: Revamp Guidance Approach by Using Advisory Opinions”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “CDS Coalition Petitions FDA”2 minute read
- Media CoverageBradley Merrill Thompson, James Boiani Quoted in "Attorneys Question Usefulness of New Combo Products Pre-RFD Process"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Says It Won't Regulate Fitbit, Many Other Fitness Wearables"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Guidance Confirms Agency Won't Actively Regulate Low Risk General Wellness Products"1 minute read
- PublicationsUnderstanding the Food and Drug Administration's Jurisdiction Over Laboratory-Developed Tests and Divisions Between Food, Drug, and Cosmetic Act-Regulated and Clinical Laboratory Improvement Amendments of 1988-Regulated Activities3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Guidance Regulates Device, Software Changes"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Guidance Could Improve Cybersecurity"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Outlines When New Clearances Are Needed for Existing Devices"2 minute read
- Media CoverageJames Boiani Quoted in "FDA's New Combo Products Pilot Distinct from Planning Office Proposals"2 minute read
- Media CoverageBradley Merrill Thompson Discusses How the FDA's Final Guidance on Low-Risk Devices Will Affect Wearables, in Multiple Publications2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "What It Will Take for Theranos to Make a Comeback"2 minute read
- Media CoverageRobert Wanerman's Theranos Analysis Showcased in General Counsel News2 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA's Final Guidance on Low Risk Devices, in Multiple Publications2 minute read
- Media CoverageJames Boiani Quoted in "FDA IVD Codevelopment Guide Seen as Step Toward Consistent Reviews"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Google's App a Medical Device?"1 minute read
- PublicationsNext-Generation Sequencing: FDA Issues New Guidance for Genetic Tests15 minute read
- EventsThe Effect of the Average Manufacturer Price Final Rule on Drug Pricing and Contracting, Part 2: Opportunities and Barriers in Pharmaceutical Pricing3 minute read
- EventsCorrecting Misinformation in Social Media: When, Where, Why and How to Do It1 minute read
- EventsThe Effect of the Average Manufacturer Price Final Rule on Drug Pricing and Contracting, Part 1: The Impact of the AMP Final Rule: Legal, Operational, and Financial Considerations3 minute read
- Events340B Coalition 20th Annual Summer Conference2 minute read
- Firm AnnouncementsModern Healthcare Again Ranks Epstein Becker Green Among Top 10 Largest Health Care Law Firms2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Attorneys Want FDA to Improve Postmarket Compliance Guidance”1 minute read
- Media CoveragePatricia Wagner Quoted in "FDA Offers Guidance in Support of Sharing Device Data with Patients"1 minute read
- PublicationsPatricia Wagner Quoted in "FDA Issues Draft Guidance on Sharing Medical Device Data with Patients"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Will Allow Device Makers to Use Symbols in Labels"1 minute read
- EventsSeton Hall Law U.S. Healthcare Compliance Certification Program: An Overview of Federal Health Care Programs for Drug and Device Manufacturers1 minute read
- Media CoveragePatricia Wagner Quoted in "FDA Guidance on Device Data Sharing Aligns With HIPAA: Attorney"2 minute read
- EventsFDA Regulatory Environment for Wearables, Implantables, and Other Digital Health Devices - Wearables Crash Course Webinar Series2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Industry Lawyer Urges FDA to Release Combo Product Final Rule"2 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "Devices May Be Over-the-Hill, but Regulatory Developments and Challenges Show No Signs of Slowing Down"1 minute read
- Media CoverageAmy Dow Quoted in "FDA Seeks Comments on Draft 3-D Device Printing Guidance"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Republican Senators Press FDA on Use of Draft Guidances"2 minute read
- Events2016 FDLI Annual Conference: Current Trends in Medical Device Law: Wearables and MMAs1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Drug, Device Divisions Not on Same Page?"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Concerns: Drugs and Devices"2 minute read
- Media CoverageJames Boiani Quoted in "Proposed Theranos CEO Ban Ups Ante for Lab Testing Cos."2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Health Apps: Unlimited Promise or 'Like Having a Really Bad Doctor'"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FTC Guidance Tells Health App Makers What Laws Apply"1 minute read
- PublicationsSuccess of Opioid Addiction Bill Would Rely On Funding2 minute read
- Media CoverageBradley Merrill Thompson Discusses FTC's Stance on Mobile Health App Regulation, in Multiple Publications2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Coalition Survey Highlights CDS Uncertainty"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Medical Software Industry Again Calls for Better Regulations"2 minute read
- Media CoverageBradley Merrill Thompson Discusses the Senate HELP Committee's Passage of the MEDTECH Act, in Multiple Publications2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate Bill Imposes Limits on FDA Regulation of Apps, Software"2 minute read
- Events16th Annual Employee Health Care Conference: Video vs. Phone in Telemedicine – Getting the Facts Straight1 minute read
- Media CoverageBradley Merrill Thompson Mentioned in "Senate Tweaks Bill to Let FDA Step in If Health Software Poses Serious Risk"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Unveils Updated Combination Products Effort"1 minute read
- Media CoverageBradley Merrill Thompson Featured in "FDA May Change Refurbished Device Oversight, Attorney Says"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Hypertense About Blood Pressure App"1 minute read
- Firm AnnouncementsEpstein Becker Green's Amy Dow Named to Law360 Life Sciences Editorial Advisory Board1 minute read
- Media CoverageBradley Merrill Thompson Discusses Software Developers' Need for MEDTECH Act, in Multiple Publications2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FTC Action Risks Stifling Innovation, Health App Inventor Says"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Seeks Feedback on Plan for Medical Device Interoperability"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Software Companies Push FDA for Guidance on Decision Support Tools"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Surely You Must Be Postal”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Meets With Clinical Decision Support Firms to Address Challenging Cases”2 minute read
- Media CoverageJames Boiani Quoted in “Troubled Health Start-Up Theranos Faces Washington Reckoning”1 minute read
- Media CoverageBradley Merrill Thompson Featured in Podcast Q&A, "Combo Product Human Factors Guidance Follows Multi-Year Coalition Effort"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Combination Products Design Draft Guidance"1 minute read
- Media CoverageConstance Wilkinson Quoted in "Long-Awaited AMP Rule Heralds Shift to Acquisition Cost-Based Reimbursement"2 minute read
- Media CoverageBethany Hills Quoted in "FDA's Proposed LDT Model Would Hinder Next-Gen DNA Tests, Cancer Expert Says"1 minute read
- PublicationsCMS Issues Final Rule on Covered Outpatient Drugs38 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Device Interoperability Guide Offers Clarity, But Lacks Incentives"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Feds: Theranos's Deficiencies Put Patient Safety in 'Immediate Jeopardy'"1 minute read
- Media CoverageBradley Merrill Thompson Discusses FDA's Draft Guidance on Medical Device Interoperability with Multiple Publications2 minute read
- PublicationsNYSBA Committees Comment on FDA Guidance and Legislation2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Class Action Filed Against Fitbit in the US Over Accuracy Claims”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Due to This Obscure Loophole, Some Medical Tests Avoid Oversight”2 minute read
- PublicationsNew FDA Guidance Advances Pharma Manufacturing Tech1 minute read
- Media CoverageRobert Wanerman Quoted in "Common Rule Update Expected to Dominate Regulatory Landscape in 2016"2 minute read
- Media CoverageBenjamin Zegarelli Quoted in "Federal Agencies Train Spotlight on Social Media Ads"1 minute read