FDA issues Roche Molecular Systems an emergency use authorization for its cobas SARS-CoV-2 test for diagnosing coronavirus (COVID-19).
FDA releases the FDA-483 with nine observations from an inspection at Fusion IV Pharmaceuticals.
FDA finalizes a guidance on Competitive Generic Therapies which describes the process that generic drug applicants should follow to request designatio...
FDA asks and answers frequently asked questions about Covid-19 independent lab tests under the agencys new immediately-in-effect guidance.
CDER issues a MAPP on developing and publishing digital content on the FDA Drugs Web site.
Federal Register notice: FDA makes available a final guidance entitled Q3D(R1) Elemental Impurities.
Federal Register notice: FDA announces a 4/16 public meeting entitled Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Cli...
Federal Register notice: FDA reopens the comment period indefinitely on a notice seeking scientific data and information about the safety, manufacturi...