Federal Register notice: FDA withdraws two guidances Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C ...
FDA warns Denver, CO-based Hygienic Labs that it has not responded to multiple requests for records and information so the agency can assess the quali...
Bristol Myers Squibb says it will seek approval for a subcutaneous formulation of its Opdivo (nivolumab) for use in patients with advanced or metastat...
FDA posts a revised guidance entitled Development and Licensure of Vaccines to Prevent Covid-19.
Nine FDAers discuss the agencys use of real-world data and real-world evidence, and the confusion that exists on those terms and how they are used in ...
FDA publishes a guidance on CBERs voluntary consensus standards recognition program for regenerative therapy products.
Federal Register notice: FDA withdraws approval of eight ANDAs after the applicants notified the agency that they were no longer marketed.
FDA adds 171 devices to its list of AI/ML-enabled medical devices.
