An new CDER regulatory science report details the agencys efforts to ease bioequivalence requirements for locally-acting orally inhaled and nasal drug...
FDA posts a guidance on Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices.
FDA delays the effective date of portions of a final rule that would have revised the agencys existing regulations describing the types of evidence th...
Public Citizen questions FDAs delay in banning from the market all hydroxyethyl starch intravenous solutions, a move the European Medicines Agency rec...
FDA approves a GlaxoSmithKline supplemental BLA for an expanded indication for Fluarix Quadrivalent (influenza vaccine) to include use in those six mo...
FDAs Bone, Reproductive and Urologic Drugs Advisory Committee votes against a candidate for testosterone replacement therapy in adult males for condit...
FDA asks DC federal court to reject United Therapeutics suit seeking to require the agency to grant seven years of marketing exclusivity to the compan...
FDA orders labeling changes to limit pediatric use of opioid cough and cold medicines.