67 matches.
- PublicationsSolving the EDDO Guidance Puzzle1 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
- BlogsA Final Rule Bites the Dust: Federal Court Rules FDA Lacks Authority to Regulate LDTs2 minute read
- Media CoverageMegan Robertson Quoted in “5 Tips for Building a Predetermined Change Control Plan”3 minute read
- Media CoverageMegan Robertson Featured in “Alumni Stories: Genetics and Law: Class of 2014”4 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
- Media CoverageMegan Robertson Quoted in “AI in Medtech Is Taking Off. Here Are 4 Trends to Watch in 2025.”2 minute read
- Media CoverageMegan Robertson Quoted in “FDA Wrapped: Prominent Guidance from 2024”2 minute read
Firm AnnouncementsEpstein Becker Green Announces 2025 Promotions4 minute read- Firm AnnouncementsEpstein Becker Green Attorneys Honored for Excellence in the Legal Profession by Best Lawyers 202514 minute read
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs
FDA Releases Laboratory-Developed Tests Final Rule- 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
- BlogsMaking Moves – FDA’s LDT Proposed Rule Sent to OMB for Review2 minute read
- Media CoverageMegan Robertson Featured in “Women in STEM: The Stories of Five Women Scientists with Clemson Ties”4 minute read
- Media CoverageMegan Robertson Quoted in “FDA and CMS Leaders Unite Over Proposed Lab Test Rule”2 minute read
Firm AnnouncementsEpstein Becker Green Awards 2023 Annual Core Values Champions4 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
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown4 minute read
-
Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs
- BlogsFDA Issues Final Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors4 minute read
- Firm AnnouncementsEpstein Becker Green Attorneys Recognized by 2024 Best Lawyers for Excellence in the Legal Profession12 minute read
- BlogsFDA’s LDT Proposed Rule Heads to the White House2 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
- PublicationsFDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials20 minute read
-
Direct Access Laboratory Testing: Physician Orders and Specimen Collection
-
Direct Access Laboratory Testing: Reimbursement & Compliance
-
Direct Access Laboratory Testing: Navigating the Regulatory Landscape
- PublicationsLegal Landscape for Fertility Treatment in the U.S. in the Wake of Dobbs – Some Answers, More Open Questions. What Will 2023 Deliver?4 minute read
-
Post-Dobbs: Considerations for Clinical Trials and Research
- PublicationsIn Vitro Diagnostic (IVD) Devices2 minute read
- BlogsThe VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to Fruition6 minute read
- PublicationsHospitals and Hospital System Boards Should Review Sole Source Procurement Policies and Procedures2 minute read
-
Chevron Deference: Is It Time for Change?
-
Federal and State Cannabis Rules Are Moving in Different Directions
- PublicationsCannabis Conundrum: Demonstrating “Accepted Medical Use” in a Restricted Research Environment2 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
-
Holding Pattern: Cannabis Industry Waits for FDA Regulatory Rulemaking
- BlogsFDA Issues Draft Guidance on Cannabis Clinical Research and Sends CBD Enforcement Discretion Guidance to OMB for Review8 minute read
- BlogsFederal Courts Say They Will Decide Cases Against CBD Product Manufacturers When the Smoke Clears4 minute read
-
Telehealth Flexibility: Key Regulatory Changes Impacting Providers During and Beyond the Coronavirus Pandemic
- PublicationsHow Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?3 minute read
- BlogsFDA Authorizes the First Home Collection of Specimens to Be Tested for COVID-192 minute read
- BlogsFDA Issues Update to Guidance for Clinical Trials During the COVID-19 Pandemic6 minute read
- BlogsFDA Confirms That At-Home Collection Kits Are Not Authorized for Use with COVID-19 Tests2 minute read
- BlogsFDA Issues Guidance for Ongoing Clinical Trials During COVID-19 Pandemic5 minute read
- PublicationsCBD DD: Key Considerations When Conducting Due Diligence on Cannabis Companies2 minute read
- BlogsAfter Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs4 minute read
- PublicationsTo Eat or Not to Eat: CBD "Edibles" Receive Mixed Reaction from States and Steady Opposition from FDA2 minute read
- BlogsFDA Hosts Long-Awaited Cannabis Public Hearing6 minute read
- PublicationsCBD Scrutiny May Signal Broader FDA Enforcement Trend3 minute read
- BlogsFDA Commissioner Gottlieb Says Agency Will Not Tolerate Deceptive Marketing of CBD Products; Issues Warning Letters3 minute read
- BlogsCBD “Edibles” Face Opposition from States, FDA4 minute read
- Media CoverageMegan Robertson, Lauren Farruggia Featured for FDLI Presentation on FDA Software Regulation2 minute read
- EventsFood and Drug Law Institute: Developments in FDA Software Regulation1 minute read
- PublicationsOIG Portfolio Highlights Hospice Fraud and Quality-of-Care Concerns11 minute read
- PublicationsNew Gene Therapy Guidances Signal Anticipated Growth of Product Submissions by FDA11 minute read
- EventsStrategic Health Care Investments: Part II - Autism Condition Providers4 minute read
- BlogsCheers to 80 Years: Celebrating the Anniversary of the Federal Food, Drug, and Cosmetic Act14 minute read
- PublicationsCheers to 80 Years of the Food, Drug, and Cosmetic Act1 minute read
- EventsStrategic Health Care Investments: Part I - Substance Abuse Disorder Providers5 minute read
- BlogsHHS OIG Inspector General Announces New Compliance Resource Portal2 minute read
- PublicationsObstacles in the Path? Medicare’s National Coverage Determination on Next-Generation Sequencing Has Significant Implications for Precision Medicine11 minute read
- Events3rd Annual Healthcare Law & Compliance Boot Camp for Healthcare Providers1 minute read