Federal Register notice: FDA extends the comment period on its draft guidance entitled Platform Technology Designation Program for Drug Development....
CDER director Patrizia Cavazzoni and CBER director Peter Marks say they are co-leading a new FDA Rare Disease Innovation Hub.
FDA publishes a guidance with its compliance policy about blood establishments failing to comply with some donor eligibility requirements.
Endo recalls (Class 1) one lot of clonazepam orally disintegrating tablets 0.25 mg due to mislabeling on the cartons of some packs that shows the wron...
FDA clears a Hyperfine 510(k) for the ninth generation of artificial intelligence-powered Swoop magnetic resonance software.
Bayer says it will present positive results from a Phase 3 Nubeqa prostate cancer trial to FDA to consider a potential indication expansion for the dr...
FDA accepts for priority review an Atara Biotherapeutics BLA for gene therapy tabelecleucel, indicated as monotherapy for treating Epstein-Barr virus-...
The FDA FY 2023 drug and medical device establishment inspection report lists registered establishments and inspections by type and world region.
