Federal Register notice: FDA sends to OMB an proposed information collection entitled Requests for Nonbinding Feedback After Certain FDA Inspections o...
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...