Federal Register notice: FDA determines the regulatory review period for patent extension purposes for GlaxoSmithKline Biologicals Shingrix vaccine.
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.
FDA issues a final guidance entitled Acceptance Review for De Novo Classification Requests.
Federal Register notice: FDA determines the regulatory review period for La Jolla Pharmaceuticals Giapreza (angiotensin II).