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Federal Register

Pfizer Wins Priority Review Voucher for Paxlovid

Federal Register notice: FDA issues a priority review voucher to Pfizer after determining that its Paxlovid tablets meet the criteria for a material t...

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Human Drugs

Lawmakers Want FDA Jurisdiction on Execution Drugs

Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) urge the Department of Justice to rescind its Office of Legal Counsels 2019 opinion blocking F...

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Federal Register

Palacio Debarred Over FDA False Statements

Federal Register notice: FDA permanently debars Jessica Palacio from providing services to any person that has approved or pending drug product applic...

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Medical Devices

Respironics Recalls OmniLab Ventilator

Philips Respironics recalls (Class 1) its OmniLab Advanced + Ventilator because the device may experience an interruption or loss of therapy.

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Medical Devices

Panel Backs Shield Colon Cancer Test

An FDA advisory committee recommends the approval of a Guardant Health PMA for the Shield blood test for colorectal cancer screening in adults age 45 ...

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Human Drugs

Hospira Recalls Buprenorphine and Laberalol Lots

Pfizers Hospira drug unit recalls (Class 1) several lots of buprenorphine HCl injection Carpuject units and labetalol HCl injection Carpuject units du...

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Human Drugs

Vyaire Medical Recall Twin Tube Lines

Vyaire Medical recalls (Class 1) its Twin Tube sample lines, which are used on the Vyntus CPX Cardiopulmonary Exercise Test, due to the potential for ...

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Federal Register

Draft Guide on Vet Drug Residues

Federal Register notice: FDA makes available a draft revised guidance entitled Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human...

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Medical Devices

IDE for Brain Interchange Implant in Stroke Therapy

FDA approves a CorTec IDE to allow the University of Washington School of Medicine to conduct a study involving the closed-loop Brain Interchange Impl...

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Human Drugs

Laurus Labs Cited on GMPs in India

FDA cites Laurus Labs (Hyderabad, India) over GMP deficiencies following a 12/2023 inspection at the firms active pharmaceutical ingredient manufactur...