FDA issues a final rule to amend the medical device GMP requirements of the Quality System regulation to harmonize and modernize the regulation with i...
FDA has completed a bioresearch monitoring inspection and mid-cycle review meeting for the Abeona Therapeutics BLA for pz-cel.
FDA releases the forms FDA-483 issued following inspections at four drug manufacturing facilities in three countries.
FDA publishes a final rule amending the medical device Quality System Regulation to harmonize it with an international standard used in other countrie...
FDA releases a revised biosimilar research roadmap to help researchers develop proposals for funding under BsUFA 3.
The Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee schedules a 2/6 hearing on shortcomings in the FDA foreign...
Biogen discontinues the further development and commercialization of controversial Alzheimers drug Aduhelm (aducanumab-avwa) as part of a move to repr...
CBER releases its guidance agenda for 2024 that includes a listing of topics upcoming guidances will address.
