46 matches.
- BlogsFull Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown
Direct Access Laboratory Testing: Future FDA Proposed Regulations on LDTs- PublicationsA Topic-Based Analysis of FDA Responses to FOIA Requests1 minute read
- BlogsUnpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?
- BlogsUnpacking Averages: Searching for Bias in Word Embeddings Trained on FDA Regulatory Documents18 minute read
- PublicationsIs CMS Ignoring the Realities of Biopharmaceutical Costs?2 minute read
- BlogsUnpacking Averages: FDA FOIA Response Times by Topic of Request23 minute read
- PublicationsA Patchwork in Need of Permanent Repair: The U.S. Framework for Recommending and Covering Preventive Care2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “The FDA Plans to Regulate Far More AI Tools as Devices. The Industry Won’t Go Down Without a Fight”2 minute read
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Direct Access Laboratory Testing: Navigating the Regulatory Landscape
- Media CoverageBradley Merrill Thompson Quoted in “Why Congress Quietly Just Gave the FDA More Power”3 minute read
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Unpacking FDA's Final Clinical Decision Support Guidance
- BlogsFDA Issues Orphan Drug Exclusivity Policy That Could Be a Catalyst for Future Litigation8 minute read
- PublicationsCOVID-19 Vaccine Prices Are Going Up. It Shouldn’t Be Our Focus.2 minute read
- BlogsUnpacking Averages: Creating an Industry-Specific Index to Track the FDA Regulatory Environment15 minute read
- BlogsUnpacking Averages: Finding Medical Device Predicates Without Using FDA’s 510(k) Database6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Torres Says Regulatory Alignment a Pressing Consideration for AI Change Control Draft”October 24, 20222 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software to Predict Risk of Sepsis, Stroke Should Be Regulated as a Medical Device, Says FDA”October 11, 20224 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Acknowledges Shortcomings of Pre-Cert Pilot in Report”October 3, 20226 minute read
- BlogsUnpacking Averages: Using Natural Language Processing to Extract Quality Information from MDRsOctober 3, 202214 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Talks Takeaways from Software Precert Pilot”September 27, 20222 minute read
- BlogsUnpacking Averages: Assessing FDA’s Focus on Enforcing 510(K) Requirements on ImportsSeptember 6, 202212 minute read
- Media CoverageBradley Merrill Thompson Mentioned in “FDA Draft for Digital Tech in Clinical Trials Languishes Despite Agency’s Digital Push”September 1, 20221 minute read
- PublicationsCOVID-19 Vaccination and the Fetal Cell Line Conundrum for Employee Religious ObjectionsAugust 11, 202210 minute read
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program”August 3, 20222 minute read
- PublicationsCOVID-19 Vaccine and Monoclonal Coverage: A Focus of the 2023 Medicare Physician Fee Schedule Proposed RuleAugust 1, 202210 minute read
- Media CoverageRichard Hughes’ Article on Immunization Access Cited in “A Twenty-First Century 'Vaccines for Children' Program”July 12, 20223 minute read
- BlogsUnpacking Averages: Common Root Causes Driving Medical Device RecallsJuly 5, 20229 minute read
- EventsBIO International Convention: Vaccine Innovation and the Future of Life-Course ImmunizationJune 14, 20222 minute read
- BlogsUnpacking Averages: Violations Found in Medical Device Warning LettersJune 1, 202214 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Ends Pre-Cert but Could Revisit in the Future, with Congress’ Help”May 31, 20222 minute read
- BlogsThe VALID Act: Senate Action Brings FDA Regulation of LDTs Closer to FruitionMay 20, 20226 minute read
- PublicationsDeconstructing Genus Medical Technologies, LLC v. FDA: A Misunderstood Court Decision16 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Racial Equity Increasing in Device Trials, but Reporting Remains Low”March 29, 20222 minute read
- Media CoverageBradley Merrill Thompson Quoted in “3 Key FDA Topics for Medtechs in 2022”February 2, 20224 minute read
- Media CoverageBradley Merrill Thompson Mentioned in “FDA Combo Products Guidance Offers More Flexibility for Cross-Labeling”January 31, 20222 minute read
- BlogsUnpacking Averages: Likelihood of FDA Medical Device InspectionsJanuary 4, 20226 minute read
- PublicationsPrescription Digital Therapeutics Don't Need a Physician3 minute read
- BlogsUnpacking Averages: FDA Review Time for 510(k)s5 minute read
- PublicationsCommentary: Digital Health Companies Should Stay Away from FDA in 20212 minute read
- EventsMulti-Cancer Early Detection Through Novel Blood Tests: Developing Appropriate Regulatory and Reimbursement Pathways1 minute read
- PublicationsPostmarket Responsibilities for Medical AI: Part III — FDA Should Not Expand Its Oversight of Commercialized AI3 minute read
- BlogsCurrent Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk Management5 minute read
- PublicationsPostmarket Responsibilities for Medical AI: Part II — What Industry Should Do in Commercializing Medical AI2 minute read
- PublicationsPost-Market Responsibilities for Medical AI: Part I – FDA's Plan to Increase Its Oversight3 minute read
- Blogs7 Hot Health Care Industry Sectors for Investment, Growth & Consolidation in 20205 minute read
