FDA completes a pre-approval product inspection at Indias Strides Pharma Sciences with three inspection observations.
FDA grants OBI Pharma an orphan drug designation for OBI-3424 for treating acute lymphoblastic leukemia.
Federal Register notice: FDA makes available a draft guidance entitled Product Identifiers Under the Drug Supply Chain Security Act Questions and Answ...
FDA describes its approach to seeking civil money penalties from those failing to follow ClinicalTrials.gov submission requirements and FDA certificat...
CDER director Janet Woodcock says the agency is considering whether it has new authorities available under FDASIA it can use to address drug shortages...
Federal Register notice: FDA makes available a final guidance entitled Product Identifier Requirements Under the Drug Supply Chain Security Act Compli...
Federal Register notice: FDA makes available a final guidance entitled Heparin-Containing Medical Devices and Combination Products: Recommendations fo...
Federal Register notice: FDA makes available a final guidance entitled Grandfathering Policy for Packages and Homogenous Cases of Product Without a Pr...