FDA publishes an ICH draft guideline on post-approval safety data that is available for comment.
FDA clears a Nanox AI 510(k) for HealthFLD, an artificial intelligence software that provides automated qualitative and quantitative analysis of liver...
Former FDAer Naomi Schwartz says medical device companies must prioritize cybersecurity compliance to meet a stricter FDA enforcement emphasis.
FDA makes available a draft guidance entitled FDA Advanced Manufacturing Technologies Designation Program.
Federal Register notice: FDA announces a 5/20-21 public workshop entitled FY 2024 Generic Drug Science and Research Initiatives Workshop.
FDA convenes a 2/13 advisory committee meeting to discuss the clinical significance of Abbott Medicals TRILUMINATE pivotal trial that evaluated the co...
FDA clears a Proscia 510(k) for its Concentriq AP-Dx, a diagnostic software for pathologists for viewing, interpreting, and managing whole slide image...
FDA removes a clinical hold against Hemogenyx Pharmaceuticals IND for the companys chimeric antigen receptor T-cells therapy for treating acute myeloi...
