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Inspections Will Suffer Under FDA Cuts: Lawyers

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Recent FDA layoffs raise concerns across the drug and biologic industries as experts warn that diminished inspection capacity coul...

Hill Staffer Graham Appointed to FDA Policy Office

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FDA appoints Capitol Hill staffer Grace Graham as deputy commissioner for policy, legislation, and international affairs.

FDA Wants Contractors to Replace Some Fired Staff

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FDA is recruiting contractors to do the travel logistics work for inspections and investigations that was done by staff who have b...

2 Medical Device FAQs Issued

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FDA issues two documents answering frequently asked questions about reporting medical device recalls, corrections, and adverse eve...

Celltrions Humira Biosimilar Now Interchangeable: FDA

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FDA grants interchangeable biosimilar status to Celltrions Yuflyma (adalimumab-aaty), a biosimilar copy of AbbVies Humira.

Trump to FDA: Boost Generics, OTCs, Rx Imports

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A presidential executive order tells FDA to suggest administrative and legislative ways to improve the availability of generic and...

Petition Seeks GMP Amendment for Sampling Logbooks

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A citizen petition urges FDA to amend the requirements under 21 CFR Part 211 (finished pharmaceuticals GMPs) to mandate the use of...

Naturista Store Markets Unapproved Drug: FDA

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FDA warns Downey, CA-based Naturista Store that it is marketing an unapproved, misbranded drug as a dietary supplement that contai...

CGMP Issues Found in PMS4PMS Inspection

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FDA warns Clarence, NY-based PMS4PMS that it is illegally marketing a misbranded over-the-counter menstrual cream that is manufact...

FDA Clears eGenesis Perfusion Trial

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FDA clears a Phase 1 human trial of an eGenesis porcine liver for use with an OrganOx system for perfusion of intensive care patie...