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Human Drugs

Centera, CEO Sentenced Over Unapproved Drugs

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

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Human Drugs

J&J Reports Positive Data on Nipocalimab

Johnson & Johnson reports positive data from two studies involving its monoclonal antibody nipocalimab, supporting the drugs potential use in generali...

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Human Drugs

Guidance on Reporting Listed Drug Amounts

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

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Human Drugs

Ainos Responds to Clinical Hold on Covid Therapy

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

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Federal Register

Glaucoma Pressure Reducer Goes to Panel

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

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Human Drugs

Insight Recalls TING Athletes Foot Spray

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

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Federal Register

EUAs Revoked for 2 Covid Tests

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

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Medical Devices

Cardinal Health Recalls Urology/Operating Trays

Due to an earlier Nurse Assist, LLC product recall, Cardinal Health is recalling products supplied to it for use in Covidien and Cardinal Health brand...

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Human Drugs

Vertex Plans Mid-year Cystic Fibrosis NDA

Vertex Pharmaceuticals plans to file an NDA by mid-year and use a priority review voucher for its cystic fibrosis combination drug, once-daily vanzaca...

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Human Drugs

Rep. Waltz Questions FDAs Telework Policy

Congressman Mike Waltz (R-FL) asks FDA for clarification on the agencys telework policies which have minimized the operational standards for approving...