[ Price : $8.95]
FDA issues a final rule to amend the medical device GMP requirements of the Quality System regulation to harmonize and modernize t...[ Price : $8.95]
FDA has completed a bioresearch monitoring inspection and mid-cycle review meeting for the Abeona Therapeutics BLA for pz-cel.[ Price : $8.95]
FDA releases the forms FDA-483 issued following inspections at four drug manufacturing facilities in three countries.[ Price : $8.95]
FDA publishes a final rule amending the medical device Quality System Regulation to harmonize it with an international standard us...[ Price : $8.95]
FDA releases a revised biosimilar research roadmap to help researchers develop proposals for funding under BsUFA 3.[ Price : $8.95]
The Subcommittee on Oversight and Investigations of the House Energy and Commerce Committee schedules a 2/6 hearing on shortcoming...[ Price : $8.95]
Biogen discontinues the further development and commercialization of controversial Alzheimers drug Aduhelm (aducanumab-avwa) as pa...[ Price : $8.95]
CBER releases its guidance agenda for 2024 that includes a listing of topics upcoming guidances will address.