137 matches.
- 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
2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration- 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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The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs
- 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
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
- 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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Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
- 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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Direct Access Laboratory Testing: Navigating the Regulatory Landscape
- 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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Trends in Enforcement of Dietary Supplements: Thought Leaders in Health Law Video Series
- 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