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A new GAO report finds that FDA has ongoing efforts to help drug manufacturers identify the circumstances under which they could b...[ Price : $8.95]
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for GlaxoSmithKline Biologicals...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Humanitarian Device Exemption (HDE) Program.[ Price : $8.95]
Federal Register notice: FDA announces that it accepted a priority review voucher to approve AbbVies Rinvoq (upadacitnib) on 8/16....[ Price : $8.95]
CDER director Janet Woodcock urges drug compounding outsourcing facilities to appropriately label their drugs with adverse event r...[ Price : $8.95]
FDA issues a final guidance entitled Acceptance Review for De Novo Classification Requests.[ Price : $8.95]
Federal Register notice: FDA determines the regulatory review period for La Jolla Pharmaceuticals Giapreza (angiotensin II).[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Drugs for Treatment of Partial Onset Seizures: Full Extrapo...