Federal Register notice: FDA makes available a final guidance entitled Humanitarian Device Exemption (HDE) Program.
Federal Register notice: FDA announces that it accepted a priority review voucher to approve AbbVies Rinvoq (upadacitnib) on 8/16.
CDER director Janet Woodcock urges drug compounding outsourcing facilities to appropriately label their drugs with adverse event reporting information...
FDA Review posts the Federal Register notices for the week ending 9/6/2019.
FDA Review posts product approval summaries for the week ending 9/6/2019.
CDER director Janet Woodcock says addiction currently is the most serious threat to public health.
FDA approves Boehringer Ingelheim Pharmaceuticals Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in certain adults with ...
FDA issues a final guidance entitled Acceptance Review for De Novo Classification Requests.