Federal Register notice: FDA extends the comment period on a 9/23 notice about three draft guidance documents related to CDRHs Accreditation Scheme fo...
Attorney Deborah Livornese says FDA wants user feedback on the NDA integrated review format it has been publishing for several years.
Federal Register notice: FDA makes available a final guidance requesting the reconsideration of an ANDA decision at the division level.
Staska Pharmaceuticals recalls one lot of ascorbic acid solution for injection (500mg/mL, 50mL vials) due to the presence of glass particulates in som...
FDA publishes a guidance with recommendations for collecting a core set of patient-reported clinical outcomes in cancer clinical trials.
FDA places a clinical hold on the Novavax IND for a Covid-19/influenza combination vaccine and influenza standalone vaccine following a report of one ...
FDA publishes a guidance reflecting GDUFA 3 provisions on the procedures for ANDA applicants to follow in requesting reconsideration of scientific iss...
FDA clears a Bracco Diagnostics and Subtle Medical 510(k) for their artificial intelligence-powered software AiMify for brain MRIs.
