Federal Register notice: FDA cancels an 8/8-planned public workshop on developing antiviral drugs for treating adenoviral infection.
Federal Register notice: FDA makes available a guidance entitled Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials...
Federal Register notice: FDA makes available a draft guidance entitled Harmonizing Compendial Standards with Drug Application Approval Using the USP P...
Federal Register notice: FDA makes available a draft guidance entitled Using the Inactive Ingredient Database.
FDA issues a draft guidance to help NDA and BLA sponsors apply population PK analysis.
FDA issues a draft guidance with recommendations for clinical trials to establish effectiveness and safety for hormonal drug contraceptives.
Omeros and FDA agree to a response-based primary endpoint for its pivotal trial to support a BLA for narsoplimab to treat hematopoietic stem cell tran...
FDA accepts for review a Neurocrine Biosciences NDA for opicapone, a once-daily, oral, selective catechol-O-methyltransferase inhibitor as an adjuncti...