An FDA safety alert says that an environmental carcinogen that has recently been plaguing blood pressure and heart medicines has now spread to some ra...
FDA says it will develop bioanalytical best practices for biosimilar biological product development.
FDA warns that Pfizers Ibrance (palbociclib), Novartis Kisqali (ribociclib), and Eli Lillys Verzenio (abemaciclib) used to treat some patients with ad...
KRS Global Biotechnology recalls all lots of unexpired human and animal drugs due to sterility concerns.
FDA says Sterigenics contract sterilization facility in Atlanta, GA is temporarily closed while it undergoes construction to reduce ethylene oxide emi...
FDA clears a Qfix 510(k) for the Encompass 15-Channel Head Coil, a diagnostic imaging device for use with the Encompass MR SRS Immobilization Device.
Federal Register notice: FDA posts a list of ninee information collections that have been approved by OMB.
FDA publishes four guidances giving its thinking on several aspects of the 510(k) submission process.