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FDA grants OBI Pharma an orphan drug designation for OBI-3424 for treating acute lymphoblastic leukemia.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Product Identifiers Under the Drug Supply Chain Security Ac...[ Price : $8.95]
FDA describes its approach to seeking civil money penalties from those failing to follow ClinicalTrials.gov submission requirement...[ Price : $8.95]
CDER director Janet Woodcock says the agency is considering whether it has new authorities available under FDASIA it can use to ad...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Product Identifier Requirements Under the Drug Supply Chain...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Heparin-Containing Medical Devices and Combination Products...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Grandfathering Policy for Packages and Homogenous Cases of ...[ Price : $8.95]
FDA releases an ADMA Biologics FDA-483 with eight inspection observations.