Janssen files a supplemental NDA for a new indication to expand Xareltos (rivaroxaban) use in patients with peripheral artery disease.
Federal Register notice: FDA makes available a final standard memorandum of understanding entitled Memorandum of Understanding Addressing Certain Dist...
FDA revises its template that provides current recommendations about data and information that should be submitted to support an Emergency Use Authori...
FDA accepts for review a Santen NDA for cyclosporine topical ophthalmic emulsion, 0.1% for treating severe vernal keratoconjunctivitis (VKC) in patien...
FDA lifts a clinical hold against AstraZeneca and the University of Oxford to resume clinical trials of their coronavirus vaccine, AZD1222.
FDA Review posts the Federal Register notices for the week ending 10/23/2020.
Federal Register notice: FDA makes available a final guidance entitled Wholesale Distributor Verification Requirement for Saleable Returned Drug Produ...
CDRH officials say they are looking to identify the least amount of information that device companies need to support a declaration of conformity to a...