320 matches.
- BlogsLitigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast41 minute read
- Litigating Nutrition: Class Action Battles Over Dietary Supplements
- Media CoverageJames Boiani Quoted in “Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval”5 minute read
- PublicationsThe Legal and Reputational Risks Associated with Greenwashing3 minute read
- EventsLife Sciences AI Summit: Navigating FDA and EMA Directives - Shaping AI’s Role in the Life Sciences2 minute read
- Media CoverageBob Hearn Quoted in “Concerns Mount as More States Adopt Biomarker Laws”2 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
- 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
- Dietary Supplements: Navigating the Regulatory Maze
- Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
- BlogsInfluencers, Brand Ambassadors and Marketers Take Note – FTC Has Finalized Updates to Its Endorsement Guides7 minute read
- PublicationsDietary Supplement Makers Face "Misbranding" Minefield, Need FDA Guidance7 minute read
- Events11th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements: Class Action Boot Camp2 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2023 Southern California Rising Stars List6 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
- EventsAHLA Telemedicine Webinar Series: Hot Topics in Tele-Behavioral Health1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Draft Guidance Allows AI/ML Devices to Evolve Without Requiring New Submissions”5 minute read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
- 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
- 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
- Media CoverageBradley Merrill Thompson Quoted in “Trade Group Pushes Back on FDA’s Clinical Decision Support Guidance”3 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in “And Over at FDA …”2 minute read
- PublicationsFTC’s Revisions to Dietary Supplement Advertising Guidelines: More of the Same2 minute read
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 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
- Media CoverageBradley Merrill Thompson Quoted in “Torres Says Regulatory Alignment a Pressing Consideration for AI Change Control Draft”2 minute read
- Media CoverageJames Boiani Quoted in “Testing Overhaul Faces a ‘Narrow Pathway’ to Pass Before Year End, Industry Groups Say”3 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 “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
- Media CoverageBradley Merrill Thompson Featured in Medtech Monthly Podcast: Breakthrough Device Analysis7 minute read
- Firm AnnouncementsEpstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law2 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
- PublicationsRecent Actions Highlight That Price Fixing Reaches Beyond Agreements on the Ultimate Price1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Senate HELP Sends User Fee Reauthorization Bill to Floor Vote”2 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
- Firm AnnouncementsEpstein Becker Green’s Theodora McCormick Recognized as a Trailblazing Change-Maker by the Executive Women of New Jersey4 minute read
- Firm AnnouncementsThirteen Attorneys Named to the 2022 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
- Firm AnnouncementsEpstein Becker Green’s Managing Director James P. Flynn Named a “Leader in Law”4 minute read
- EventsAmerican University Business Law Review Spring Symposium: Developing Safeguards for AI Caused Gender Bias in Business1 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
- Firm AnnouncementsEpstein Becker Green Announces 2022 Promotions6 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
- Media CoverageBradley Merrill Thompson Quoted in “Clinical Decision Support Guidance Tops FDA’s Agenda for 2022”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA's 2022 A-List Guidance Plan Hits on Software, Post-Pandemic Future”4 minute read
- EventsThe Year in Review: Food and Dietary Supplement Industry Trends, Key Court Decisions, and Litigation DevelopmentsSeptember 28, 20211 minute read
- Media CoverageJames Boiani Quoted in “Covid Test Makers Told to Update Labeling in Wake of Mutations”2 minute read
- EventsAuthor Happy Hour: Evolving Food and Dietary Supplement Class Action Suits1 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
- PublicationsFood and Supplement Class Action Suits That Rely on Alleged Regulatory Violations2 minute read
- Firm AnnouncementsTen Epstein Becker Green Attorneys Named to 2021 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
- PublicationsDistinguishable Products and Tying Claims in Health Care Markets3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Regulation of AI Complicated by Hospital’s Use of In-House Algorithms”4 minute read
- PublicationsData Quality for AI in Healthcare2 minute read
- Media CoverageJames Boiani Quoted in “Regulatory Attorney Says Warning Letters Likely to Spike Under New FDA Administration”3 minute read
- 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 Finalizes Speedier Medical Device Pathway Alternative to Breakthrough Status”3 minute read
- EventsFDLI Enforcement, Litigation, and Compliance Conference: FTC and SEC Litigation, Enforcement, and Application to FDA Authorities1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Prescription Pulse: Experts Split on HHS Sunset Rule”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “AdvaMed Seeks Regulatory Clarity on FDA’s New Digital Health Center”2 minute read
- Media CoverageBradley Merrill Thompson Featured in MobiHealthNews HIMSSCast: “Is the FDA Taking Digital Health Regulation in the Right Direction?”2 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
- Media CoverageBradley Merrill Thompson Quoted in “FDA Touts Lessons from Pre-Cert, Though Next Steps Murky”3 minute read
- PublicationsBusinesses Beware: FTC Seeks to Codify “Made in USA” Enforcement Policy4 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Device Makers Want FDA to Preview Post-Pandemic Flexibility Plans"3 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 "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
- 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
- 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
- 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
- PublicationsFDA and FTC Join Forces to Promote Biosimilars3 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
- 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
- Media CoverageBradley Merrill Thompson Quoted in "FDA's Special Treatment of Big Tech Faces Mounting Scrutiny"3 minute read
- PublicationsApplying Data Science Principles to FDA's PreCert Program: Some Scary Stuff3 minute read
- Events10th Anniversary CNS Summit: Digital Therapeutics1 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 "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
- 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
- Media CoverageBradley Merrill Thompson Quoted in "Combination Product Reporting Rule Set for 2020 Enforcement"2 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 "Pear Files Insomnia and Depression Software as Pre-Cert Pilot 510(k)"3 minute read
- Media CoverageAlaap Shah Quoted in "Can Pacemakers (and Other Medical Devices) Really Be Hacked?"2 minute read
- EventsNEHI: Next Generation Therapies - What's Next?1 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
- 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
- Media CoverageBradley Merrill Thompson Quoted in "Device Expert Worries FDA Might Not Get Takers for Pre-Cert Test Plan"2 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 Quoted in "Experts Raise Concerns with FDA Draft Guidance on Combo Product Reviews"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 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
- EventsMarketing Best Practices in Light of the SUPPORT for Patients and Communities Act: Trends in Behavioral Health Webinar Series4 minute read
- PublicationsHow Many Companies Stand to Benefit from the FDA Pre-Cert Program? Fewer Than You Might Think2 minute read
- EventsHow the Opioid Crisis and the SUPPORT Act Created a New Enforcement Reality: Trends in Behavioral Health Webinar Series3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "510(k) Modernization: FDA Floats Need to Pursue New Authority"2 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 "Lawyer: FDA Digital Health Report Reassuring, But Short on Safety Tips"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 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
- EventsBio/Pharma Compliance Congress on Non-Promotional Activities: Off-Label Enforcement and Emerging High-Risk Areas Needing Heightened Oversight1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA's De Novo Pathway Is About to Get a Makeover"2 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 Rolls Out New Rx-Use-App Paper"2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Senate Democrats Raise Major Concerns October 11, with FDA Software Pre-Cert Plan"2 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
- PublicationsCDRH’s New Post-Market Paradigm: Why the Public Should Be Worried3 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 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 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
- 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 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
- 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 CoverageBradley Merrill Thompson and CDS Coalition Discuss the FDA’s Draft Guidance on Clinical Decision Support4 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
- Firm AnnouncementsEpstein Becker Green Named a 2017 "Health Practice Group of the Year" by Law3602 minute read
- Media Coverage"FDA Guidance on Decision Support Software: Implications for Industry" Featured in POLITICO Morning eHealth2 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Outlook 2018: Pharma/Life Sciences Law and Policy"2 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
- 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 "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
- EventsAMDM 2017 Focus Meeting: CLIA Waiver Updates1 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
- 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
- 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 "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
- PublicationsLearning from Experience: FDA's Treatment of Machine Learning2 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 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
- Media CoverageJames Boiani Quoted in "Combo Product Appeals Low in Number, but Lengthy in Decision Time"2 minute read
- Events2017 BIO International Convention: Medical Device Regulations1 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 CoverageBradley Merrill Thompson Quoted in "Will a New FDA User Fee Discourage Medical Device Innovation?"3 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Cyber on Stage"1 minute read
- EventsCombination Products Regulation, Policy & Best Practices: Combination Products - Perspective of the Combination Products Coalition1 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
- Media CoverageBradley Merrill Thompson Quoted in "CDS Tools Fall Short in Meeting Physicians' Needs in Care Delivery"2 minute read
- PublicationsHow Machine Learning Can Support Clinical Decision-Making – and Leave the Doctor in Control1 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
- Media CoverageBradley Merrill Thompson Discusses States' Mobile Health App Regulations2 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 "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 "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
- 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
- Media CoverageBradley Merrill Thompson Quoted in "Big Pharma Objects to New Hurdles for Off-Label Drug, Device Promotion"1 minute read
- PublicationsThe Legal Environment for Precision Medicine1 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
- PublicationsBusiness Strategies for Technology Companies Wanting to Play in the Health Care Internet of Things2 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 "FDA Clarifies Rule on Tobacco Products in Medical Realm"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Final Rule Clarifies When Tobacco Products Are Regulated as Drugs, Devices"2 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 "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
- Trends in Digital Health: Thought Leaders in Health Law Video Series
- Media CoverageBradley Merrill Thompson Quoted in "Congress Sends Cures Legislation to President"2 minute read
- EventsTCT 2016 (Transcatheter Cardiovascular Therapeutics)1 minute read
- Events2016 SupplySide West Conference: Developing and Substantiating Product Claims1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "Google's App a Medical Device?"1 minute read
- EventsCorrecting Misinformation in Social Media: When, Where, Why and How to Do It1 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 CoverageHelaine Fingold Quoted in “New Marketing Guidelines Contain More Tweaks than Major Changes”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FDA Will Allow Device Makers to Use Symbols in Labels"1 minute read
- Media CoverageBradley Merrill Thompson Quoted in "FTC Guidance Tells Health App Makers What Laws Apply"1 minute read
- Firm AnnouncementsEpstein Becker Green's Amy Dow Named to Law360 Life Sciences Editorial Advisory Board1 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