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...
The Washington Post says three sources have indicated the Biden administration is close to bringing former FDA commissioner Robert Califf back into se...
FDA says the Abbott Molecular recall of two SARS-CoV-2 test kits is Class 1.
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.
FDA approves Lillys Verzenio CDK4/6 inhibitor for certain breast cancer patients as determined by an FDA-approved diagnostic test.