96 matches.
- 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- PublicationsThe LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold16 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
- EventsFDLI Food and Dietary Supplement Safety and Regulation: Enforcement Update - a Look at Both Governmental and Private Litigation1 minute read
- BlogsA Regulatory Haze of Uncertainty Continues as the Clock Ticks Toward Phase One of FDA’s LDT Final Rule4 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
- PublicationsEmbrace the Chaos: AI Regulation in the US Remains in Flux2 minute read
- EventsIPMI Healthcare Law & Compliance Institute: Headwinds and Tailwinds Arising Out of the 2025 Regulatory and Legislative Landscape1 minute read
- BlogsVideo: 2025 Outlook - the Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care3 minute read
2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration- 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
- EventsLondon Healthcare Conference: The Year of Elections - Impact for Life Sciences Operations Across US, EU, and UK1 minute read
- Media CoverageFeatured in Law360: Epstein Becker Green Adds Research Compliance Pro Elizabeth McEvoy2 minute read
- Firm AnnouncementsEpstein Becker Green Welcomes High-Stakes Research Misconduct Attorney and Litigator Elizabeth J. McEvoy, Improves Bench Amid Federal Enforcement Surge3 minute read
Firm AnnouncementsEpstein Becker Green Announces 2025 Promotions4 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
- BlogsExemptions from the Drug Supply Chain Security Act Enhanced Drug Distribution Security Requirements7 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 CoverageMarylana Saadeh Helou Quoted in “FDA Offers Road Map for Remote Trials, but Questions Linger”2 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
- PublicationsSumming Up the FDA's Long-Anticipated Draft Guidance on Diversity Action Plans3 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
- 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
- Media CoverageStuart Gerson Quoted in “FDA’s Lab Developed Test Rule Could Be First Check on Agency’s Power Post-Chevron”3 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
- EventsUnpacking the Legal Challenges in Sourcing AI in Health Care and Life Sciences in the US and the EUJune 17 and 21, 202410 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
- BlogsNuts or Not Nuts? Second Circuit Declines to Consider Whether KIND’s Use of All-Natural Is Deceptive, Misleading5 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
- BlogsFederal Update on Cannabis Scheduling: Are State Legalized Cannabis Dispensaries to Become Pharmacies?7 minute read
- Media CoverageKate Heffernan Featured in AHLA’s Speaking of Health Law Podcast, “Trends Related to Research Misconduct”1 minute read
- EventsABA 2024 HIV Law & Practice Conference: HIV Healthcare – Developments and Possibilities1 minute read
- Events2024 NCICP: Legal Landscape for Vaccination1 minute read
- EventsFDLI Food and Dietary Supplement Safety and Regulation: Dietary Supplement Regulatory Updates – Focus on Agency Enforcement1 minute read
- Media CoverageJames Boiani Quoted in “$42M Rat-Infestation Fine Underscores Sanitation Risks Facing Warehouses”3 minute read
- EventsLife Sciences AI Summit: Navigating FDA and EMA Directives - Shaping AI’s Role in the Life Sciences2 minute read
- EventsAHLA: Advising Providers – Legal Strategies for AMCs, Physicians, and HospitalsFebruary 5–7, 20242 minute read
- Media CoverageMegan Robertson Quoted in “FDA and CMS Leaders Unite Over Proposed Lab Test Rule”2 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
- Publications9th Circ. Scienter Ruling May Strengthen FDA's Leverage1 minute read
- EventsWorld Vaccine Congress West Coast: How Are NITAGs & HTAs Thinking About Novel Antibody Products?1 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 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
- Media CoverageJames Boiani Quoted in “FDA Moves to Modernize Medical Devices Premarket Program”3 minute read
- BlogsFDA Oversight of AI Software Developed by Health Care Providers23 minute read
- PublicationsDietary Supplement Makers Face "Misbranding" Minefield, Need FDA Guidance7 minute read
- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory Framework26 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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The Legal Battle Over Mifepristone
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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
- Media CoverageJames Boiani Quoted in “The Hazy Future of the VALID Act”2 minute read
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Direct Access Laboratory Testing: Reimbursement & Compliance
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Direct Access Laboratory Testing: Navigating the Regulatory Landscape
- EventsAdvanced Topics in Clinical Research2 minute read
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
Firm AnnouncementsEpstein Becker Green Announces 2023 PromotionsOctober 28, 20225 minute read- Media CoverageJames Boiani Quoted in “Testing Overhaul Faces a ‘Narrow Pathway’ to Pass Before Year End, Industry Groups Say”3 minute read
- Firm AnnouncementsEpstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law2 minute read
- EventsNWABR Hybrid IRB Conference: Privacy Pile-Up—Making Sense of Multiple Frameworks for Research Participant Privacy and Data ProtectionJuly 28, 20221 minute read
- Firm AnnouncementsJessika Tuazon Named to the 2022 Southern California Rising Stars List5 minute read
- EventsAHLA Academic Medical Centers and Teaching Hospitals Law Institute 2022: Precision Medicine Studies—A Perfect Storm of Legal and Ethical Issues on the Line Between Treatment and ResearchFebruary 2, 20222 minute read
- PublicationsFDA's Ingredient Advisory List Raises Due Process Concerns2 minute read
Firm AnnouncementsEpstein Becker Green Announces 2022 Promotions6 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 CoverageJames Boiani Quoted in “FDA Has Broad Regulatory Options for Mixing Covid Boosters”3 minute read
- Media CoverageJames Boiani Quoted in “Covid Test Makers Told to Update Labeling in Wake of Mutations”2 minute read