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Federal Register notice: FDA posts a list of ninee information collections that have been approved by OMB.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled The Special 510(k) Program.[ Price : $8.95]
An FDA safety alert says that an environmental carcinogen that has recently been plaguing blood pressure and heart medicines has n...[ Price : $8.95]
FDA says it will develop bioanalytical best practices for biosimilar biological product development.[ Price : $8.95]
FDA warns that Pfizers Ibrance (palbociclib), Novartis Kisqali (ribociclib), and Eli Lillys Verzenio (abemaciclib) used to treat s...[ Price : $8.95]
KRS Global Biotechnology recalls all lots of unexpired human and animal drugs due to sterility concerns.[ Price : $8.95]
FDA says Sterigenics contract sterilization facility in Atlanta, GA is temporarily closed while it undergoes construction to reduc...[ Price : $8.95]
FDA publishes four guidances giving its thinking on several aspects of the 510(k) submission process.