10 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-
Direct Access Laboratory Testing: Navigating the Regulatory Landscape
- BlogsFDA Issues Orphan Drug Exclusivity Policy That Could Be a Catalyst for Future Litigation8 minute read
- Media CoverageJames Boiani, Bradley Merrill Thompson Quoted in “And Over at FDA …”2 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 FruitionMay 20, 20226 minute read
- PublicationsDeconstructing Genus Medical Technologies, LLC v. FDA: A Misunderstood Court Decision16 minute read
- EventsMulti-Cancer Early Detection Through Novel Blood Tests: Developing Appropriate Regulatory and Reimbursement Pathways1 minute read
- BlogsCurrent Good Manufacturing Practices in the Time of COVID-19: FDA Announces New Expectations on Risk Assessment and Risk Management5 minute read
