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.
FDA tells its Vaccines and Related Biological Products Advisory Committee it has some concerns about data submitted by J&J in support of a booster sho...
FDA approves Mercks Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Unique Device Identification: Policy Regarding Global Unique...