95 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- Media CoverageJames Boiani Quoted in “Will Trump Admin. ‘Wash Its Hands’ of FDA Lab-Test Rule?”2 minute read
- Media CoverageJames Boiani Quoted in “Drug Industry Worries About FDA Delays”3 minute read
- PublicationsACIP’s Upcoming Meningococcal Recommendations: Added Complexity, Reduced Choice1 minute read
- PublicationsCMS Rule for CY 2026 Highlights AI, Behavioral Health, Anti-Obesity Drug Coverage, and More24 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
- EventsreMind Psychedelics Business Forum: How to Engage Your Cannabis Audience About Psychedelics1 minute read
- EventsSupplySide West: Ingredient Claims and Legal Flames - an Interactive Workshop to Dodge Regulatory Heat1 minute read
- EventsFDLI Food Advertising, Labeling, and Litigation Conference: Food and Dietary Supplement Litigation1 minute read
- Media CoverageBBA Spotlight Series: Get to Know Emerging Leaders in Boston Law–Marylana Saadeh Helou8 minute read
- EventsBCBS Association: Legal and Regulatory Challenges in Psychedelic Research and Commercialization2 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
- Media CoverageJames Boiani Quoted in “Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval”5 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
- PublicationsEnsure Equity and Feasibility in Updating Meningococcal Vaccine Recommendations2 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
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Direct Access Laboratory Testing: Physician Orders and Specimen Collection
- EventsAHLA Telemedicine Webinar Series: Hot Topics in Tele-Behavioral Health1 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
- 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 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
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program”2 minute read
- PublicationsRecent Actions Highlight That Price Fixing Reaches Beyond Agreements on the Ultimate Price1 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
Firm AnnouncementsEpstein Becker Green Announces 2022 Promotions6 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
- 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 CoverageJames Boiani Quoted in “Regulatory Attorney Says Warning Letters Likely to Spike Under New FDA Administration”3 minute read
- EventsFDLI Enforcement, Litigation, and Compliance Conference: FTC and SEC Litigation, Enforcement, and Application to FDA Authorities1 minute read
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Product Launching in the Era of COVID-19
- PublicationsBusinesses Beware: FTC Seeks to Codify “Made in USA” Enforcement Policy4 minute read
- Media CoverageJames Boiani Quoted in "Startups Spar with FDA Over What Constitutes a Home Coronavirus Test"3 minute read
- PublicationsFDA and FTC Join Forces to Promote Biosimilars3 minute read
- Events10th Anniversary CNS Summit: Digital Therapeutics1 minute read
- PublicationsChapter 6, "Federal Health Care Programs: Coverage and Reimbursement of Prescription Drugs and Medical Devices"2 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
- Media CoverageJames Boiani Quoted in "At-Home Tests for Influenza, Strep, Others Raising Eyebrows of Some Experts"2 minute read
- EventsMarketing Best Practices in Light of the SUPPORT for Patients and Communities Act: Trends in Behavioral Health Webinar Series4 minute read
- EventsHow the Opioid Crisis and the SUPPORT Act Created a New Enforcement Reality: Trends in Behavioral Health Webinar Series3 minute read
- EventsBio/Pharma Compliance Congress on Non-Promotional Activities: Off-Label Enforcement and Emerging High-Risk Areas Needing Heightened Oversight1 minute read
- Media CoverageRobert Wanerman Quoted in "Trump Might Pay for Some Devices Before Medicare Approval: Industry"3 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
- 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
- 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 CoverageJack Wenik's Presentation on Dietary Supplement Litigation Featured in Natural Products INSIDER2 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- EventsFDLI Advertising and Promotion Conference: Risk Information in Direct-to-Consumer Broadcast Advertisements for Prescription Drugs1 minute read
- EventsMedical Device Usability and Human Factors Engineering Conference: FDA Oversight of Human Factors Engineering for Combination Products1 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 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
- 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
- PublicationsThe Legal Environment for Precision Medicine1 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
- Events2016 SupplySide West Conference: Developing and Substantiating Product Claims1 minute read
- Firm AnnouncementsModern Healthcare Again Ranks Epstein Becker Green Among Top 10 Largest Health Care Law Firms2 minute read
- Media CoverageHelaine Fingold Quoted in “New Marketing Guidelines Contain More Tweaks than Major Changes”1 minute read
- Firm AnnouncementsEpstein Becker Green's Amy Dow Named to Law360 Life Sciences Editorial Advisory Board1 minute read