Federal Register notice: FDA announces a 9/20 Pediatric Advisory Committee to discuss pediatric-focused safety reviews.
FDA Review posts the Federal Register notices for the week ending 8/17/2019.
An FDA review of a post-approval study conducted by SynCardia Systems for its Temporary Total Artificial Heart Companion 2 Driver System finds elevate...
Federal Register notice: FDA extends the proposal period for its Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Ce...
Federal Register notice: FDA submits to OMB an information collection extension entitled Guidance for Industry: Controlled Correspondence Related to G...
Federal Register notice: FDA grants an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in ...
Federal Register notice: FDA identifies a list of device accessories for which it believes general controls are sufficient to provide reasonable assur...
FDA alerts active pharmaceutical ingredient repackagers and distributors, and finished drug manufacturers that Sichuan Friendly Pharmaceutical Co. Lim...