145 matches.
- BlogsNovel AI Laws Target Companion AI and Mental Health8 minute read
- PublicationsFDA Vaccine Suspensions: Outliers or the New Normal3 minute read
- BlogsNovel Lawsuits Allege AI Chatbots Encouraged Minors’ Suicides, Mental Health Trauma: Considerations for Stakeholders14 minute read
- BlogsHHS, FDA Target Direct-to-Consumer Drug Advertising: A Paradigm Shift in Patient-Focused Communications15 minute read
- Media CoverageJames Boiani Quoted in “FDA Signals More Oversight of Compounders in Drug Ads Crackdown”2 minute read
Firm AnnouncementsEpstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 202612 minute read- BlogsA Final Rule Bites the Dust, Part II: FDA Gives up on Regulating LDTs as Medical Devices4 minute read
Videos & Podcasts- Media CoverageJames Boiani Quoted in “Will Trump Admin. ‘Wash Its Hands’ of FDA Lab-Test Rule?”2 minute read
- PublicationsThe LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold16 minute read
- Media CoverageJames Boiani Quoted in “Drug Industry Worries About FDA Delays”3 minute read
- BlogsA Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs2 minute read
Videos & Podcasts- Media CoverageJames Boiani Quoted in “Supplement Makers Try to Latch On to GLP-1 Boom”2 minute read
- Events2024 Election: Impact on the Health Care Legal and Policy Landscape Webinar2 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 202514 minute read
- Media CoverageJames Boiani Quoted in “CMS Takes Baby Steps in New 'Breakthrough' Device Policy”2 minute read
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Videos & Podcasts
- 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
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Videos & Podcasts
- Media CoverageJames Boiani Quoted in “Jazz Pharma to Fight FDA in Court Over Rival Sleep Drug Approval”5 minute read
- BlogsIt’s Been a Long Time Coming – FDA’s Final Rule on Regulation of Laboratory Developed Tests (LDTs) as Medical Devices Has Arrived8 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
- 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
- Media CoverageJames Boiani Quoted in “FDA Moving Quickly on LDT Rulemaking as 2024 Elections, 2027 User Fee Renewal Loom”2 minute read
- BlogsFDA LDT Webinar Serves as a Reminder to Industry to Submit Comments on the Proposed Rule3 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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Videos & Podcasts
- Media CoverageJames Boiani Quoted in “NY State Database Offers Glimpse into Laboratory-Developed Testing Landscape”3 minute read
- Media CoverageJames Boiani Quoted in “FDA Moves to Modernize Medical Devices Premarket Program”3 minute read
- BlogsUnpacking Averages: Analyzing the Relationship Between MDRs and Recalls21 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
- PublicationsWhat’s on the Agenda? Laboratory Developed Tests Added to the Unified Regulatory Agenda Signals FDA Movement Toward New Regulatory Framework26 minute read
- Media CoverageJames Boiani Quoted in “The Hazy Future of the VALID Act”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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Videos & Podcasts
- BlogsFDA Issues Orphan Drug Exclusivity Policy That Could Be a Catalyst for Future Litigation8 minute read
- 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
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
- EventsLife Science Tennessee: Policy and Advocacy Update1 minute read
- EventsIsrael Rise US Program: US Reimbursement and Payor Systems
- Media CoverageJames Boiani Quoted in “Testing Overhaul Faces a ‘Narrow Pathway’ to Pass Before Year End, Industry Groups Say”3 minute read
- EventsExplainable Artificial Intelligence and Transparency: Legal Risks and Remedies for the "Black Box" ProblemJune 9, 20222 minute read
- BlogsThe VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition6 minute read
- PublicationsDeconstructing Genus Medical Technologies, LLC v. FDA: A Misunderstood Court Decision16 minute read
- EventsMicrofluidics to Address Pandemics - SARS-CoV-2 and Beyond2 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
- Media CoverageJames Boiani Quoted in “FDA Class I Medical Device Recalls on Track to Break Record in 2021”3 minute read
- Media CoverageJames Boiani Quoted in “Regulatory Attorney Says Warning Letters Likely to Spike Under New FDA Administration”3 minute read
- EventsMulti-Cancer Early Detection Through Novel Blood Tests: Developing Appropriate Regulatory and Reimbursement Pathways1 minute read
- 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
- BlogsFDA Issues Draft Guidance on Cannabis Clinical Research and Sends CBD Enforcement Discretion Guidance to OMB for Review8 minute read
- BlogsCurrent Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk Management5 minute read
- Media CoverageJames Boiani Quoted in "Psychedelic Meds Are Opening a New Frontier for Legal Work"2 minute read
- Media CoverageJames Boiani Quoted in "Startups Spar with FDA Over What Constitutes a Home Coronavirus Test"3 minute read
- Events10th Anniversary CNS Summit: Digital Therapeutics1 minute read
- Media CoverageJames Boiani Quoted in "At-Home Tests for Influenza, Strep, Others Raising Eyebrows of Some Experts"2 minute read
- Media CoverageJames Boiani Quoted in "What's Next for the Post-Gottlieb FDA"3 minute read
- Media CoverageJames Boiani Quoted in "Lawyers: FDA's CLIA Waiver Guidances Give Industry More Flexibility"2 minute read
- BlogsThe SUPPORT for Patients and Communities Act: President Trump Signs Sweeping Opioid Law2 minute read
- Media CoverageJames Boiani Quoted in "The Ins and Outs of Lab-Developed Tests"4 minute read
- Media CoverageJames Boiani Quoted in "Device Lawyer: FDA Guidances Provide Clarity on Payer Communication"2 minute read
- EventsHealth Care Without Walls: NEHI's 2018 Health Datapalooza Pre-Conference Event1 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 CoverageJames Boiani Quoted in "What Hospitals Need To Know Before Forming A Drug Co."2 minute read
- EventsThe Food and Drug Administration's Approach to Evaluating Nicotine Replacement Therapies: Public Hearing1 minute read
- Media CoverageJames Boiani Quoted in "Labs Hopeful for Less Severe Penalties for Referral Mishaps"2 minute read
- Media CoverageJames Boiani Quoted in "Life Sciences Regulation to Watch in 2018"3 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
- EventsAMDM 2017 Focus Meeting: CLIA Waiver Updates1 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys to Co-Lead Payment and Regulatory Work Streams in NEHI Health Care Without Walls Initiative5 minute read
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Videos & Podcasts
- 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
- EventsNext Generation Dx Summit: Technology Panel - Disruptive Technologies in Lab Medicine1 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
- 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
- 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
- PublicationsThe Legal Environment for Precision Medicine1 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 CoverageJames Boiani Quoted in "Life Sciences Legislation and Regulation to Watch in 2017"1 minute read
- Media CoverageJames Boiani Quoted in "What's Next for LDTs? FDA May Be Eyeing a New Game Plan"1 minute read
- Media CoverageJames Boiani Quoted in "Backers of Stricter Lab Test Policies Disappointed with FDA Delay"2 minute read
- Media CoverageJames Boiani Quoted in "Stakeholders: Codevelopment Guide Lacks Clarity on Complementary DX"1 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 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
- Media CoverageJames Boiani Quoted in "Proposed Theranos CEO Ban Ups Ante for Lab Testing Cos."2 minute read
- Media CoverageJames Boiani Quoted in “Troubled Health Start-Up Theranos Faces Washington Reckoning”1 minute read
- Media CoverageBradley Merrill Thompson, James Boiani Quoted in "House Committee Draft Bill Would Change Regulation of Diagnostic Tests"2 minute read
- PublicationsFDA Signals Tougher Approach to Animal Drug Compounding2 minute read
- PublicationsFDA Signals Restrictive Regulatory Approach in Draft Guidance on Animal Drug Compounding14 minute read
- EventsAMDM's 42nd Annual Meeting: Risk-Based Regulation of Diagnostics – LDTs, Transitional IVDs, CLIA Waivers, and Dreams of Regulatory Reform1 minute read
- Media CoverageJames Boiani Quoted in "CLIA Waiver Applications Surged in FY 2014 After a Prior-Year Lull"2 minute read
- Media CoverageBradley Merrill Thompson, James A. Boiani Quoted in "GOP Senate Will Press FDA to Ease Up"2 minute read
- Firm AnnouncementsEpstein Becker Green Promotes Four Attorneys in Its National Health Care and Life Sciences and Labor and Employment Practices3 minute read
- Firm Announcements54 Epstein Becker Green Attorneys Named to 2014 Super Lawyers and Rising Stars Lists6 minute read
- PublicationsComing Soon to a Laboratory Near You? FDA's Proposed Framework for Laboratory Developed Tests1 minute read
- PublicationsFDA Takes a Bold Step Toward Laboratory Developed Test Regulation: How Labs and IVD Manufacturers Should Prepare for the Future27 minute read
- Media CoverageBradley Merrill Thompson and James A. Boiani Mentioned in "Breaking Down the Regulation of LDTs: Moving Forward"2 minute read
- Media CoverageBradley Merrill Thompson and James Boiani Mentioned in "Breaking Down the Regulation of LDTs: Access to Innovative IVDs"2 minute read
- PublicationsWhat You Need to Know to Keep Your Company's Promotions Out of the Enforcement Spotlight2 minute read
- Media CoverageJames Boiani Quoted in "Strategic Perspectives: Drug and Device Developments: 2014 Q2 Update"1 minute read
- Media CoverageJames Boiani Quoted in "Diagnostic Testing Fight Puts FDA in a Pickle"3 minute read
- Media CoverageJames Boiani Quoted in "Coming Together on CLIA Waivers? Industry Hopes to Recruit Patients, Providers to Push Reform"3 minute read
- Media CoverageJames Boiani Quoted in "New Stakeholder Group Wants FDA to Reform CLIA Waiver Process"2 minute read
- PublicationsSix Steps to Overcome a Negative FDA Review, in MedTech1 minute read
- EventsAssociation of Medical Diagnostics Manufacturers (AMDM) 41st Annual Meeting: The Changing Regulatory and Policy Environment for In Vitro Diagnostics1 minute read
- EventsAdvaMed Molecular Diagnostics and the Changing Landscape - Considerations and Implications: The OIR Outlook for 2014 and Beyond for Molecular Tests1 minute read
- EventsAmerican Orthotic and Prosthetic Association (AOPA) Policy Forum: FDA Law for Orthotics & Prosthetics1 minute read
- Events3rd Annual Medical Device Investigator Initiated Studies Conference: Life After an FDA Audit1 minute read
- PublicationsThe Compounding Quality Act, in Bloomberg BNA's Pharmaceutical Law & Industry Report2 minute read
- PublicationsChapter 5, "In Vitro Diagnostic (IVD) Devices," in Medical Devices Law and Regulation Answer Book 2014 (Practising Law Institute)1 minute read
- PublicationsMajor Changes in Drug Compounding and Drug Distribution Requirements (Part 1 of 2)17 minute read
- EventsAssociation of Medical Diagnostics Manufacturers (AMDM) 2013 Focus Meeting: IVD Legislative Update1 minute read
- PublicationsMissing the Point (Of Care): FDA Misreading of CLIA Waiver Law Undermines Cost-Effective Health Testing, in Washington Legal Foundation1 minute read
- EventsMed Tech Webcast Series: Regulatory and IP Issues in M&A3 minute read
- EventsMed Tech Webcast Series: Managing Regulatory Intelligence3 minute read
- EventsQ1 Productions' Quality Assurance in Pharmaceutical Manufacturing: Quality Systems Related to Combination Products1 minute read
- Firm AnnouncementsEpstein Becker Green Hires 7 New Associates for Health Care and Life Sciences Practice in D.C. and New York Offices3 minute read
- PublicationsPediatric Exclusivity: A Guide to the New Provisions Under FDAAA in Food and Drug Law Institute Update1 minute read