FDA releases a guidance on Hypertension: Developing Fixed-Combination Drug Products for Treatment.
Federal Register notice: FDA seeks comments on an information collection revision for Tropical Disease Priority Review Vouchers.
FDA issues a draft guidance outlining factors it will consider when evaluating the strength of evidence provided by drug safety meta-analyses.
FDA releases its latest batch of Warning Letters that includes one medical product company Vital Rx.
FDA accepts a Dova Pharmaceuticals supplemental NDA for Doptelet (avatrombopag) for treating chronic immune thrombocytopenia in patients who have had ...
Federal Register notice. FDA seeks comments on an information collection extension for its Guidance for Industry on Individual Patient Expanded Access...
FDA cautions Atlantic Pharmacy and Compounding about insanitary conditions in its production of drug products.
A CDRH Webinar explains provisions in a recent guidance on the appropriate use of voluntary consensus standards in premarket submissions.