FDA Review posts the Federal Register notices for the week ending 9/21/2018.
Federal Register notice: FDA announces an 11/1 joint advisory committee meeting to review an Alkermes NDA for major depressive disorder.
FDA grants Pfizer a Breakthrough Therapy designation for its 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) candidate, PF-06482077.
An analysis by the Alliance for a Stronger FDA says that the agencys fiscal year 2019 appropriations, which are part of a four-bill minibus, are imper...
The FDA charges A & O Enterprises, a seller of intravenously injected therapy products (iV Cocktails), with making a range of deceptive and unsupporte...
FDA approves a Vita Medical PMA for the Recell Autologous Cell Harvesting Device for treating severe thermal burns in patients 18 years and older.
FDA grants MicuRx Pharmaceuticals fast track status and a qualified infectious disease product desgination for contezolid (MRX-I) and its prodrug cont...