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FDA Considering Radiation Sterilization Master File Pilot

[ Price : $8.95]

FDA says it is considering implementing a master file pilot program for PMA holders whose approved devices are sterilized using ra...

PMA Safety and Effectiveness Summaries Available

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Federal Register notice: FDA posts a list of PMAs that have been approved from 1/1/2021 through 2/14/2022 that have safety and eff...

FDA Approves Diabetes Drug for Weight Loss

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FDA approves a Novo Nordisk NDA for Wegovy (semaglutide) injection (2.4 mg once weekly) for treating adults with obesity or who ar...

Nephron Sterile Compounding FDA-483

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FDA releases the FDA-483 with seven observations from an inspection at West Columbia, SC-based Nephron Sterile Compounding Center.

OPDP Faults Roszet Promotion

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The CDER Office of Prescription Drug Promotion cautions Althera that a professional promotion for its cholesterol-lower drug Rosze...

Senators Introducing Interchangeable Biologics Bill

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Four senators sponsor bipartisan legislation to speed some interchangeable biologics to market.

Whistleblower Sues Lilly Over GMP-related Termination

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A former employee at Eli Lilly files a wrongful termination suit against the pharmaceutical manufacturer, claiming she was fired i...

FDA Will Update APEC Toolkit: Verbois

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CDER Office of Drug Security, Integrity, and Response director Leigh Verbois tells how the APEC toolkit will be updated to address...

BMS Settles HIV Medication Suit for $10.8 Million

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Bristol-Myers Squibb settles an HIV medication anti-competitive conduct suit for $10.8 million.

FDA Questions Safety/Efficacy of Bluebirds Eli-Cel

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FDA says it is difficult to determine the overall benefit-risk profile of Bluebird bios eli-cel (elivaldogene autotemcel) gene the...