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OBI Pharma Granted Orphan Status for Leukemia Drug

[ Price : $8.95]

FDA grants OBI Pharma an orphan drug designation for OBI-3424 for treating acute lymphoblastic leukemia.

Q&A Guide on Product Identifiers

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Federal Register notice: FDA makes available a draft guidance entitled Product Identifiers Under the Drug Supply Chain Security Ac...

Clinical Trials Penalties Guidance

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FDA describes its approach to seeking civil money penalties from those failing to follow ClinicalTrials.gov submission requirement...

FDA Mulls New Drug Shortage Authority: Woodcock

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CDER director Janet Woodcock says the agency is considering whether it has new authorities available under FDASIA it can use to ad...

Guide on Product Identifier Requirements

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Federal Register notice: FDA makes available a final guidance entitled Product Identifier Requirements Under the Drug Supply Chain...

Guide on Heparin Labeling and Safety Testing

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Federal Register notice: FDA makes available a final guidance entitled Heparin-Containing Medical Devices and Combination Products...

Guide: Grandfathering Product Sans Product Identifier

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Federal Register notice: FDA makes available a final guidance entitled Grandfathering Policy for Packages and Homogenous Cases of ...

ADMA Biologics FDA-483 Has 8 Observations

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FDA releases an ADMA Biologics FDA-483 with eight inspection observations.

FDA Sees No New Nuplazid Risks

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FDA says its review of deaths and adverse events associated with Acadias Nuplazid did not show any new or unexpected safety findin...

Advanced Manufacturing Technology Grants

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FDA awards five grants for improvements to continuous manufacturing of biological products.