Federal Register notice: FDA announces the two-year renewal of its Endocrinologic and Metabolic Drugs Advisory Committee.
Federal Register notice: FDA announces that a priority review voucher was redeemed in the 5/23 approval of United Therapeutics supplemental NDA for Ty...
A Kaiser Health News report says four states have now submitted applications to import some drugs from Canada, with others signaling interest but not ...
FDA accepts for review an Eyenovia resubmitted NDA for MydCombi ophthalmic spray, a drug-device combination product that comprises tropicamide and phe...
Federal Register notice: FDA renews for two years the charter of its Cardiovascular and Renal Drugs Advisory Committee.
Federal Register notice: FDA sends to OMB an information collection revision entitled General Drug Labeling Provisions and OTC Monograph Drug User Fee...
CDER and CBER release a $2.25 million funding opportunity announcement to assess the potential utility of real-world data to generate real-world evide...
FDA warns Indias Centrient Pharmaceuticals about significant CGMP deviations in its manufacturing of active pharmaceutical ingredients.
