Federal Register notice: FDA seeks industry organizations interested in participating in selecting nonvoting industry representatives to serve on CDRH...
FDA qualifies the first computational modeling tool to be used with a wide range of implantable active medical devices through the Medical Device Deve...
FDA releases an FDA-483 with seven observations from an inspection at the Exela Pharma Sciences outsourcing facility.
A CDER Webinar explains updates to forms FDA-3542a and 3542 and instructs participants on how to complete the forms.
FDA publishes for comment a draft guidance on early planning for pediatric evaluation of certain molecularly targeted oncology drugs.
The Senate confirms Stephen Hahn as the next FDA commissioner on a floor vote of 72-18.
FDA authorizes the de novo marketing of PerkinElmers GSP Neonatal Creatine Kinase-MM kit as an aid in newborn screening for Duchenne Muscular Dystroph...
FDA approves an Elite Pharmaceuticals ANDA for a generic version of Shires Adderall XR, indicated for treating attention deficit hyperactivity disorde...