FDA posts a final guidance entitled Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA.
Federal Register notice: FDA announces a 9/20 Vaccines and Related Biological Products Advisory Committee to discuss controlled human infection models...
FDA rejects a United Therapeutics citizen petition that asked it to withdraw tentative approval of a Liquidia Technologies NDA for Yutrepia (treprosti...
FDA clears a Guard Medical 510(k) for additional large sizes of surgical incision closures (wounds up to 25cm) for treatment with its next-generation ...
Federal Register notice: FDA classifies into Class 2 devices that are intended to detect and identify nucleic acid targets in respiratory specimens fr...
FDA grants a de novo marketing authorization to NOWDiagnostics for its at-home First To Know Syphilis Test.
Federal Register notice: FDA classifies intravenous catheter force-activated separation devices into Class 2 (special controls).
Federal Register notice: FDA classifies into Class 2 devices that are intended to detect and identify selected microbial agents that cause acute febri...
