FDA Review posts product approval summaries for the week ending 9/30/2021.
Federal Register notice: FDA makes available a draft guidance entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data to...
FDA announces a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting to discuss booster doses for both Moderna and Janssen Cov...
Merck announces its intent to seek an FDA emergency use authorization for molnupiravir, an investigational oral antiviral medicine that new data show ...
A new medical device user fee program independent assessment by Booz Allen finds that even during the pandemic and an increasing workload, CDRH contin...
Bayer recalls all unexpired Lotrimin AF and Tinactin spray products (lot numbers beginning with TN, CV or NAA) due to the presence of benzene in some ...
Federal Register notice: FDA extends the comment period for the notice entitled Genus Medical Technologies LLC Versus Food and Drug Administration; Re...