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...
Federal Register notice: FDA makes available a draft guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Ph...
Federal Register notice: FDA makes available a final guidance entitled Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulation...
The Associated Press reports that FDA has been unsuccessful in asserting regulatory control over rapidly proliferating private stem cell clinics.
FDA publishes a revised International Conference on Harmonization guidance on impurities in new drug products.
Federal Register notice: FDA posts a draft guidance entitled Investigator Responsibilities Safety Reporting for Investigational Drugs and Devices.
Federal Register notice: FDA posts a draft guidance entitled Benefit-Risk Assessment for New Drug and Biological Products.