FDA lifts a clinical hold against AstraZeneca and the University of Oxford to resume clinical trials of their coronavirus vaccine, AZD1222.
FDA defers a review action on a Spectrum Pharmaceuticals BLA for Rolontis (eflapegrastim) because of a Covid-19-related travel restriction that preven...
FDA approves a Medtronic PMA for its Abre venous self-expanding stent system for use in the iliofemoral veins in patients with outflow obstructions.
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 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...