[ Price : $8.95]
FDA issues a draft guidance responding to additional questions about FDA-1572.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled ANDAs for Certain Highly Purified Synthetic Peptide Drug Pr...[ Price : $8.95]
FDA issues a guidance with its recommendations on testing to assess medical device safety and compatibility in the magnetic resona...[ Price : $8.95]
FDA says the impact of Covid-19 on companies will result in a two-year extension of enforcement discretion of the regulation prohi...[ Price : $8.95]
Federal Register notice: FDA posts a draft guidance on Feasibility Clinical Studies for Glycemic Control devices.[ Price : $8.95]
Federal Register notice: FDA releases a final guidance that discusses non-clinical testing and clinical considerations for implant...[ Price : $8.95]
Federal Register notice: FDA makes available a draft information sheet guidance for sponsors, clinical investigators, and institut...[ Price : $8.95]
FDA extends its PDUFA action date for Omeros narsoplimab BLA.