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Info Collection on Device Inspection Feedback

[ Price : $8.95]

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

Roche EUA for Cobas Coronavirus Test

[ Price : $8.95]

FDA issues Roche Molecular Systems an emergency use authorization for its cobas SARS-CoV-2 test for diagnosing coronavirus (COVID-...

Fusion IV Pharmaceuticals FDA-483

[ Price : $8.95]

FDA releases the FDA-483 with nine observations from an inspection at Fusion IV Pharmaceuticals.

Guide on Competitive Generic Therapies

[ Price : $8.95]

FDA finalizes a guidance on Competitive Generic Therapies which describes the process that generic drug applicants should follow t...

Covid-19 Lab Test FAQs

[ Price : $8.95]

FDA asks and answers frequently asked questions about Covid-19 independent lab tests under the agencys new immediately-in-effect g...

CDER External Drugs Web Content MAPP

[ Price : $8.95]

CDER issues a MAPP on developing and publishing digital content on the FDA Drugs Web site.

Guide on Drug Elemental Impurities

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Q3D(R1) Elemental Impurities.

Meeting on Including Pregnant Women in Clinical Trials

[ Price : $8.95]

Federal Register notice: FDA announces a 4/16 public meeting entitled Scientific and Ethical Considerations for the Inclusion of P...

Comments Reopened on Cannabidiol/Cannabis Data

[ Price : $8.95]

Federal Register notice: FDA reopens the comment period indefinitely on a notice seeking scientific data and information about the...

Guide on 510(k) 3rd Party Review Program

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled 510(k) Third Party Review Program.