The Association for Accessible Medicines calls for changes to the proposed U.S.-Mexico-Canada Free Trade Agreement to better protect generic drugs and...
FDAer Abena Agyemanm says the agency has published a table of surrogate endpoints that were used or could be used to indicate efficacy in drug develop...
FDA approves Ortho Clinical Diagnostics Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator for use on Orthos Vitros 5600 Integrate...
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FDA issues a draft guidance outlining factors it will consider when evaluating the strength of evidence provided by drug safety meta-analyses.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 ...