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Guide on Reporting Drug Making Amounts

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Un...

FDA Again Cites Catalent Facility

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Bloomberg News reports that FDA inspectors found problems at a Catalent Indiana facility that is being bought by Novo Nordisk to e...

Study on Enhancing Weight-Loss Drugs

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FDA approves a Veru IND to begin a Phase 2b clinical study to evaluate enobosarm and its use in preserving muscle mass and physica...

Centera, CEO Sentenced Over Unapproved Drugs

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A federal court sentences Arizona-based Centera Bioscience and CEO Paul Eftang for distributing unapproved drugs into interstate c...

J&J Reports Positive Data on Nipocalimab

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Johnson & Johnson reports positive data from two studies involving its monoclonal antibody nipocalimab, supporting the drugs poten...

Guidance on Reporting Listed Drug Amounts

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FDA posts a final guidance entitled Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C A...

Ainos Responds to Clinical Hold on Covid Therapy

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Ainos files a clinical hold response seeking to begin a Phase 2 trial of its low-dose oral interferon (IFN)-alpha formulation Veld...

Glaucoma Pressure Reducer Goes to Panel

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Federal Register notice: FDA announces a 3/21 advisory committee meeting to discuss a de novo marketing request by Balance Ophthal...

Insight Recalls TING Athletes Foot Spray

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Insight Pharmaceuticals recalls two lots of its TING 1% Tolnaftate Athletes Foot Spray Antifungal Spray Liquid due to elevated ben...

EUAs Revoked for 2 Covid Tests

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Federal Register notice: FDA revokes the Emergency Use Authorizations for two Covid-19 tests issued to Southern California Permane...