Federal Register notice: FDA makes available a draft guidance entitled Harmonizing Compendial Standards with Drug Application Approval Using the USP P...
Federal Register notice: FDA makes available a draft guidance entitled Using the Inactive Ingredient Database.
FDA issues a draft guidance to help NDA and BLA sponsors apply population PK analysis.
FDA issues a draft guidance with recommendations for clinical trials to establish effectiveness and safety for hormonal drug contraceptives.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...
The Virginia U.S. Attorney outlines a $1.4 billion settlement with Reckitt Benckiser to resolve civil and criminal cases involving marketing of its Su...
FDA scientists develop and qualify a Tissue Mimicking Material for Preclinical Acoustic Performance Characterization Of High Intensity Therapeutic Ult...