Federal Register notice: FDA announces a 6/14-15 Vaccines and Related Biological Products Advisory Committee meeting to discuss expanded pediatric use...
FDA warns OsteoLife Biomedical about regulatory deviations in its processing of human cells, tissues, and cellular- and tissue-based products.
CDRH says it will resume processing non-Covid in vitro diagnostic pre-submissions, but generally with an extended timeline.
Researchers from Harvard University and other organizations make the case for a distributed approach to regulating clinical artificial intelligence.
Federal Register notice: FDA withdraws approval of TG Therapeutics NDA for Ukoniq (umbralisib tosylate) tablets based on a company request.
Federal Register notice: FDA announces a 6/28 Vaccines and Related Biological Products Advisory Committee meeting to discuss modifying Covid-19 vaccin...
FDA clears Abbotts next-generation FreeStyle Libre 3 14-day continuous glucose monitor.