Federal Register notice: FDA determines that U.S. Pharmaceutical Holdings Lotensin HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5...
Federal Register notice: FDA makes available a draft guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Pl...
Federal Register notice: FDA announces a 5/10 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review Akcea Therapeutics NDA.
FDA releases five guidances, developed through a new, streamlined process, to speed development of treatments for several neurological conditions.
FDA denies an Escher Fund for Autism petition asking it to withdraw approval of Amag Pharmaceuticals Makena for use during pregnancy.
Federal Register notice: FDA announces a 3/7 Oncologic Drugs Advisory Committee meeting to review Amgen supplemental BLA for Blincyto.
Federal Register notice: FDA makes available a guidance entitled Regulatory Classification of Pharmaceutical Co-Crystals.
Stakeholders react to an FDA discussion paper associated with a guidance on patient-focused drug development.