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FDA Seeks to Withdraw 4 NDAs

[ Price : $8.95]

Federal Register notice: CDER proposes to withdraw approval of four NDAs after the application holders repeatedly failed to file r...

Pfizer Wins Priority Review Voucher for Paxlovid

[ Price : $8.95]

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

Lawmakers Want FDA Jurisdiction on Execution Drugs

[ Price : $8.95]

Senators Cory Booker (D-NJ) and Elizabeth Warren (D-MA) urge the Department of Justice to rescind its Office of Legal Counsels 201...

Palacio Debarred Over FDA False Statements

[ Price : $8.95]

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

Respironics Recalls OmniLab Ventilator

[ Price : $8.95]

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

Panel Backs Shield Colon Cancer Test

[ Price : $8.95]

An FDA advisory committee recommends the approval of a Guardant Health PMA for the Shield blood test for colorectal cancer screeni...

Hospira Recalls Buprenorphine and Laberalol Lots

[ Price : $8.95]

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

Vyaire Medical Recall Twin Tube Lines

[ Price : $8.95]

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

Draft Guide on Vet Drug Residues

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

IDE for Brain Interchange Implant in Stroke Therapy

[ Price : $8.95]

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