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FDA Updates Safety Labels for Chemo Drugs

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FDA updates the safety labeling for the widely used chemotherapy drugs capecitabine (Genentechs Xeloda) and fluorouracil (multiple...

Software Assurance Guidance Supplement

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FDA publishes a guidance with recommendations on computer software assurance for computers and automated data processing systems u...

QS Violations at Flextronics America

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FDA warns Austin, TX-based Flextronics America about Quality Systems violations in its manufacturing of a continuous glucose meter...

CGMP Violations Found in Cohance Lifesciences Inspection

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FDA warns Indias Cohance Lifesciences about CGMP violations in its production of drugs at one of its manufacturing sites.

Stakeholders Perspective on Nonprescription Drug Access

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Three drug trade associations give FDA their perspectives on increasing access to nonprescription drugs.

New Device Inspection Protocol Analyzed

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Three Hogan Lovells attorneys analyze the new FDA medical device inspection compliance program and caution manufacturers to begin ...

Class I Recall of Abbott FreeStyle Libre 3 Glucose Sensors

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FDA classifies Abbott Diabetes Cares recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring ...

Trump Officials Blocked Psychedelic Drug from Voucher Program

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Media reports say senior Trump administration officials blocked a promising new psychedelic treatment for severe depression from b...

Funding Bill Reinstates FDA Pediatric Drug Voucher Program

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President Trump signs a government spending bill that officially reinstates FDAs Rare Pediatric Disease Priority Review Voucher pr...

Amgen Dismisses FDA Request to Withdraw Tavneos

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Amgen rejects an FDA request asking it to voluntarily withdraw its vasculitis drug Tavneos (avacopan) from the U.S. market due to ...