FDA accepts for priority review a Regeneron Pharmaceuticals BLA for Regen-Cov (casirivimab and imdevimab) for treating Covid-19 in non-hospitalized pa...
Federal Register notice: FDA announces an 11/16 virtual public meeting entitled Enhanced Drug Distribution Security at the Package Level Under the Dru...
Sens. Grassley and Warren urge FDA to quickly issue over-the-counter hearing aid regulations to implement their bill that was approved in 2017.
CDER Office of Compliance director Don Ashley tells the Food and Drug Law Institute that his office has been targeting three drug advertising and enfo...
FDAs Vaccines and Related Biological Products Advisory Committee votes unanimously to support Modernas request for an emergency use authorizationfor a...
FDA agrees with Booz Allen Hamilton recommendations to improve the CDRH effort to issue emergency use authorizations for tests during a public health ...
FDA says it does not plan to enforce universal device identification submission requirements for some devices it considers to be Class 1 consumer heal...
CDER leaders say they are expanding Center efforts to promote advanced manufacturing techniques for drugs.