304 matches.
- EventsACC Chicago Roundtable: Agency Action Challenges in the Second Trump Administration2 minute read
- EventsThree I’s - Biosecurity & Research Integrity 2025: PHS Final Rule on Research Misconduct – What Institutions Need to Know2 minute read
- BlogsPodcast: Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care2 minute read
Breaking Down the Shifting Vaccine Policy Landscape- BlogsAligning Business Goals with Legal Strategies Amid Regulatory Change – Speaking of Litigation Video Podcast41 minute read
Aligning Business Goals with Legal Strategies Amid Regulatory Change- PublicationsSolving the EDDO Guidance Puzzle1 minute read
- Media CoverageJames Boiani Quoted in “Will Trump Admin. ‘Wash Its Hands’ of FDA Lab-Test Rule?”2 minute read
- BlogsPodcast: Executive Actions Impact Federally Funded Research - What Institutions Should Do Now – Diagnosing Health Care2 minute read
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Executive Actions Impact Federally Funded Research: What Institutions Should Do Now
- Media CoverageJames Boiani Quoted in “Drug Industry Worries About FDA Delays”3 minute read
- BlogsPodcast: Criminal Health Care Fraud Enforcement - Projections for 2025 and Beyond – Diagnosing Health Care2 minute read
- BlogsCourt Sides with RICO Complainant Who Received Tainted Medical Marijuana and with FDA on Regulating E-Cigarettes - SCOTUS Today10 minute read
- Media CoverageJack Wenik Quoted in “RFK Jr’s HHS Showing Mixed Signals for Dietary Supplement Sector”4 minute read
- Media CoverageMegan Robertson Quoted in “5 Tips for Building a Predetermined Change Control Plan”3 minute read
- EventsFDLI Food and Dietary Supplement Safety and Regulation: Enforcement Update - a Look at Both Governmental and Private Litigation1 minute read
- PublicationsACIP’s Upcoming Meningococcal Recommendations: Added Complexity, Reduced Choice1 minute read
- EventsAUTM 2025 Annual Meeting: Navigating Academic Integrity in Research - Lessons Learned from Research Misconduct1 minute read
- Media CoverageMegan Robertson Quoted in “Loper Bright No Free Pass Where FDA’s LDT Rule Is Concerned”2 minute read
- EventsFDLI Digital Health Technology and Regulation: The Next-Gen Regulatory Arena1 minute read
- Media CoverageKevin Malone Featured in AHLA’s Speaking of Health Law Podcast, “Trends in Digital Therapeutics”1 minute read
- BlogsVideo: 2025 Outlook - the Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care3 minute read
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2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration
- EventsAHLA: The Complexities of AI in Health Care3 minute read
- Media CoverageMegan Robertson Quoted in “AI in Medtech Is Taking Off. Here Are 4 Trends to Watch in 2025.”2 minute read
- EventsProfs and Pints DC: The New Politics of Public Health2 minute read
- Media CoverageMegan Robertson Quoted in “FDA Wrapped: Prominent Guidance from 2024”2 minute read
- Media CoverageJames Boiani Quoted in “Supplement Makers Try to Latch On to GLP-1 Boom”2 minute read
- EventsFDLI Enforcement, Litigation, and Compliance ConferenceDecember 10-11, 20241 minute read
- EventsLondon Healthcare Conference: The Year of Elections - Impact for Life Sciences Operations Across US, EU, and UK1 minute read
Firm AnnouncementsEpstein Becker Green Announces 2025 Promotions4 minute read- EventsPRIM&R Annual Conference: Decentralized Clinical Trials and the Community Dimension - Advantages and Challenges2 minute read
- EventsASPL Developments in Pharmacy Law Seminar: Regulatory, Industry, and Legal Perspectives on the Future of the DSCSA3 minute read
- EventsSupplySide West: Ingredient Claims and Legal Flames - an Interactive Workshop to Dodge Regulatory Heat1 minute read
- Media CoverageLisa Pierce Reisz Quoted in “New Health Apps May Pose Challenges to Patient Privacy”3 minute read
- EventsMAGI@home 2024: Collaboration Over Confrontation - CTA Negotiation Tips & Tricks1 minute read
- EventsThe REAL Summit Fall 2024: The Intersection of Finance & Mental Health2 minute read
- EventsDiabetes Technology Meeting: Who Can Sell Your Data - a United States Perspective1 minute read
- EventsCombination Products Summit: Regulatory and Technical Considerations for On-Body Delivery Systems (OBDS)1 minute read
- Media CoverageKate Heffernan Quoted in “Colleges Get More Leeway to Handle Research Misconduct”2 minute read
- Media CoverageBBA Spotlight Series: Get to Know Emerging Leaders in Boston Law–Marylana Saadeh Helou8 minute read
- Media CoverageChristopher Smith Quoted in “HDA 2024 Traceability Seminar: A Legal Perspective Regarding DSCSA”5 minute read
- EventsHDA 2024 Traceability Seminar: Legal Perspectives for DSCSA Compliance Teams1 minute read
- Media CoverageDavid Shillcutt Quoted in “Proposed Digital Therapy Codes Good Idea with Barriers: Experts”2 minute read
- EventsNACDS Total Store Expo: The DSCSA and Chain Drug Stores - Recent Developments and the Future1 minute read
- Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
- EventsNCURA Annual Meeting: Key Challenges in Navigating Research Misconduct Proceedings2 minute read
- BlogsPodcast: The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care2 minute read
- BlogsPodcast: The Future of Laboratory Testing Just Got a Little Clearer - FDA's Final Rule on LDTs – Diagnosing Health Care2 minute read
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The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs
- EventsAdolescent Meningococcal Vaccines: Impact and Potential Changes1 minute read
- BlogsPodcast: Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court – Diagnosing Health Care2 minute read
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Down Goes Chevron: A 40-Year Precedent Overturned by the Supreme Court
- PublicationsFDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans16 minute read
- EventsMultipurpose Prevention Technology (MPT) Summit: Experiences from Other Fields to Help Address MPT Roadblocks1 minute read
- EventsBCBS Association: Legal and Regulatory Challenges in Psychedelic Research and Commercialization2 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 CoverageRachel Snyder Good Quoted in “A First in State AI Law”2 minute read
- EventsBCBS Association: The World of Emerging Therapies and Alternative Substances in Healthcare2 minute read
- BlogsLitigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast41 minute read
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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
- EventsLife Sciences AI Summit: Navigating FDA and EMA Directives - Shaping AI’s Role in the Life Sciences2 minute read
- PublicationsEnsure Equity and Feasibility in Updating Meningococcal Vaccine Recommendations2 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
- EventsASPL Developments in Pharmacy Law Seminar: Drug Supply Chain Security Act Changes and Implications for Dispensers2 minute read
- Media CoverageRachel Snyder Good Quoted in “'Devil's in the Details' of Biden's AI Health Plans, Experts Say”3 minute read
- EventsFDA's LDT Proposed Rule: A Discussion1 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
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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 Year27 minute read
- Events11th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements: Class Action Boot Camp2 minute read
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Post-Dobbs: One Year Later
- 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
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Direct Access Laboratory Testing: Physician Orders and Specimen Collection
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Legal and Regulatory Landscape for Psychedelics as Therapies
- 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
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Direct Access Laboratory Testing: Reimbursement & Compliance
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Direct Access Laboratory Testing: Navigating the Regulatory Landscape
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Unpacking FDA's Final Clinical Decision Support Guidance
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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 CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 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
- 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
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program”2 minute read
- PublicationsFDA Greenlights Pharmacists to Prescribe COVID-19 Drug Paxlovid13 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2022 Southern California Rising Stars List5 minute read
- Firm AnnouncementsThirteen Attorneys Named to the 2022 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
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Firm AnnouncementsEpstein Becker Green Again Recognized as One of the Largest Health Care Law Firms2 minute read
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Entrepreneurship in Biotech: Growing Your Business
- PublicationsDeconstructing Genus Medical Technologies, LLC v. FDA: A Misunderstood Court Decision16 minute read
- EventsMicrofluidics to Address Pandemics - SARS-CoV-2 and Beyond2 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 CoverageEpstein Becker Green Insight on CMS Proposal to Repeal Medicare Coverage of Breakthrough Devices Featured in Orthopedics This Week3 minute read
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Is the Dietary Supplement Regulatory Framework Working?
- EventsThe Year in Review: Food and Dietary Supplement Industry Trends, Key Court Decisions, and Litigation DevelopmentsSeptember 28, 20211 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
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
- 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 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
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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
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The Biden Administration's First 100 Days
- 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
- EventsGCMI Virtual Experiential Learning Program: Reimbursement Pathways1 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 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
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Key Considerations for Reshoring U.S. Drug Manufacturing
- Media CoverageEpstein Becker Green’s Latest Health Hires in Boston Featured in Law3602 minute read
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Product Launching in the Era of COVID-19
- 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
- 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
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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
- Firm AnnouncementsEpstein Becker Green Ranks Highly as One of the Largest Health Care Law Firms by Modern Healthcare2 minute read
- Firm AnnouncementsFive Epstein Becker Green Attorneys Named to 2020 Southern California Rising Stars List6 minute read
- Media CoverageJames Boiani Quoted in "Psychedelic Meds Are Opening a New Frontier for Legal Work"2 minute read
- Firm AnnouncementsSixteen Epstein Becker Green Attorneys Named to 2020 Washington, DC, Super Lawyers and Rising Stars Lists5 minute read
- Media CoverageJames Boiani Quoted in "Startups Spar with FDA Over What Constitutes a Home Coronavirus Test"3 minute read
- PublicationsThe CARES Act: Key Provisions for Health Care Providers7 minute read
- EventsAPhA2020: The Drug Cost Controversy, Part 2 – What's Next?1 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
- EventsFood and Drug Law Institute 2019: Enforcement, Litigation, and Compliance Conference - the Current State of Dietary Supplement Enforcement1 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
- Firm AnnouncementsEpstein Becker Green Lauded by 2020 U.S. News – Best Lawyers "Best Law Firms" Survey4 minute read
- Events10th Anniversary CNS Summit: Digital Therapeutics1 minute read
- Publications8 Best Practices for Cannabis Transaction Due Diligence1 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
- 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
- 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
- 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
- Media CoverageJames Boiani Quoted in "At-Home Tests for Influenza, Strep, Others Raising Eyebrows of Some Experts"2 minute read
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Trends in Cybersecurity of Medical Devices: Thought Leaders in Health Law Video Series
- 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
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Trends and Legal Risks in Medical Marijuana: Thought Leaders in Health Law Video Series
- Media CoverageRobert Wanerman Quoted in "CMS Floats New Add-On Payment Route for Breakthrough Devices"2 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
- PublicationsCBD Scrutiny May Signal Broader FDA Enforcement Trend3 minute read
- EventsFood Enforcement and Compliance Conference: Criminal Enforcement1 minute read
- PublicationsFDA Proposes to Clarify and Formalize the De Novo Classification Process for Medical Devices1 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
- PublicationsThe Criminalization of Dietary Supplement Enforcement3 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
- 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
- EventsU.S. Healthcare Compliance Certification Program1 minute read
- Media CoverageRobert Wanerman Quoted in "Trump Might Pay for Some Devices Before Medicare Approval: Industry"3 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
- PublicationsNew Gene Therapy Guidances Signal Anticipated Growth of Product Submissions by FDA11 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 CoverageJames Boiani Quoted in "Device Lawyer: FDA Guidances Provide Clarity on Payer Communication"2 minute read
- PublicationsCheers to 80 Years of the Food, Drug, and Cosmetic Act1 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
- Firm AnnouncementsSeventeen Epstein Becker Green Attorneys Named to 2018 Washington DC Super Lawyers and Rising Stars Lists5 minute read
- Media CoverageJames Boiani Quoted in "FDA Wants to Ease Diagnostic/Drug Combo Study Paperwork"2 minute read
- EventsFDLI: Introduction to US Medical Device Law and Regulation - Overview of Medical Device Law and Regulation Organizational Structures1 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 CoverageJames Boiani Quoted in "What Hospitals Need To Know Before Forming A Drug Co."2 minute read
- Media CoverageAmy Dow Quoted in "Compassionate Use: A Look into Goldwater Institute v. HHSand 'Right to Try' Legislation"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
- 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
- Media CoverageJames Boiani Quoted in "Life Sciences Regulation to Watch in 2018"3 minute read
- Media CoverageJack Wenik's Presentation on Dietary Supplement Litigation Featured in Natural Products INSIDER2 minute read
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Trends in Precision Medicine: Thought Leaders in Health Law Video Series
- 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 CoverageJames Boiani Quoted in "FDA Final Guidance on Drug/Device Classifications Misses the Mark, Attorneys Say"2 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
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Trends in Enforcement of Dietary Supplements: Thought Leaders in Health Law Video Series
- EventsFDLI Advertising and Promotion Conference: Risk Information in Direct-to-Consumer Broadcast Advertisements for Prescription Drugs1 minute read
- EventsSupplySide West: FDA Lawsuits and Class Action Litigation in the Dietary Supplement Industry1 minute read
- EventsNJHA and NJSBA Annual Joint Meeting: Focus on the Opioid Epidemic - Enforcement and Prevention1 minute read
- EventsMedical Device Usability and Human Factors Engineering Conference: FDA Oversight of Human Factors Engineering for Combination Products1 minute read
- EventsSpecialty Pharma Association Regulatory Workshop: Pharmacovigilance Agreements1 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
- PublicationsPrivacy Implications for Biotechnology2 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 CoverageMark Lutes Featured in MCOL ThoughtLeaders: Outcomes-Based Pricing Arrangements3 minute read
- Media CoverageStuart Gerson Quoted in "Fallout from OIG Report May Be Light"1 minute read
- Media CoverageConstance Wilkinson Quoted in "Top Four Approaches to Reduce Pharmaceutical Costs"2 minute read
- Media CoverageJames Boiani Quoted in "FDA Takes Steps Toward Creating Lab Accreditation System for Evaluating Medical Devices"2 minute read
- Media CoverageStuart Gerson, Bradley Merrill Thompson Quoted in "Bipartisan House Bills Take Aim at Unsafe Medical Devices"3 minute read
- Firm AnnouncementsSixteen Epstein Becker Green Attorneys Named to 2017 Washington DC Super Lawyers and Rising Stars Lists5 minute read
- PublicationsTrump, Gottlieb, and the Cures Act: What Pharmaceutical Manufacturers Need to Know15 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 CoverageJames Boiani Quoted in "Combo Products Won't Get Special Review Pathway at US FDA Anytime Soon"1 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
- PublicationsSix Key Changes to the Common Rule13 minute read
- Media CoverageStuart Gerson Quoted in "Gorsuch's Antipathy to Agency Rules May Boggle Health Industry"2 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
- Media CoverageStuart Gerson Quoted in "Obama's FDA Leaves Mark with Last-Minute Policy Blitz"2 minute read
- Media CoverageJames Boiani Quoted in "Life Sciences Legislation and Regulation to Watch in 2017"1 minute read
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Trends in Digital Health: Thought Leaders in Health Law Video Series
- 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
- 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 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 CoverageJames Boiani Quoted in "FDA Delays UDI Date for Some Devices as It Finishes Convenience Kit Guide"1 minute read
- Media CoverageBradley Merrill Thompson, James Boiani Quoted in "Attorneys Question Usefulness of New Combo Products Pre-RFD Process"2 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 CoverageJames Boiani Quoted in "FDA's New Combo Products Pilot Distinct from Planning Office Proposals"2 minute read
- Media CoverageRobert Wanerman's Theranos Analysis Showcased in General Counsel News2 minute read
- Media CoverageJames Boiani Quoted in "FDA IVD Codevelopment Guide Seen as Step Toward Consistent Reviews"2 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
- 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
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