FDA commissioner Scott Gottlieb and CDRH director Jeffrey Shuren propose a digital health Center of Excellence.
FDA releases the FDA-483 with five observations from an inspection at Indias Live Pharmaceuticals.
FDA accepts for review a Sanofi and Regeneron Pharmaceuticals supplemental BLA for Praluent (alirocumab) to update the Prescribing Information to incl...
FDA grants Syntimmune an orphan drug designation for SYNT001 for treating pemphigus.
FDA accepts for priority review a supplemental BLA for Keytruda, an anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or ...
FDA publishes a guidance recommending technical specifications and general considerations for submitting certain ANDA comparative clinical endpoint bi...
A Tufts Center for the Study of Drug Development analysis shows that central nervous system drugs take longer to develop and approve than drugs in oth...
FDA warns two Medtronic manufacturing facilities about Quality System violations in their production of cardiac medical devices.