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Human Drugs

FDA Relaxes Promotion Restrictions on Covid EUAs

FDA relaxes advertising and promotion restrictions placed on six Covid-19 emergency use authorizations.

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Human Drugs

Advanced Compounding Hit With FDA-483

FDA posts a seven-item Form FDA-483 from an inspection of New England Life Care (dba Advanced Compounding Solutions) earlier this year.

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Biologics

Advisory Panel Shoots Down Y-mAbs BLA

An FDA advisory committee unanimously votes to not recommend approval of a Y-mAbs Therapeutics BLA for I-omburtamab.

Medical Devices

510(k) Addresses FDA Hemodialysis Machine Concerns

FDA clears a Fresenius Medical 510(k) to implement changes to its 2008T hemodialysis machines that addresses an earlier FDA safety alert.

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Human Drugs

Panel Mixed on GSK Anemia Drug Due to Safety

An FDA advisory committee votes to recommend approval of GlaxoSmithKlines anemia drug daprodustat for use in treating chronic kidney disease in adult ...

Medical Devices

California Court Upholds Preemption for Medtronic

Attorney Michelle Yeary says a California state court granted Medtronic summary judgment on several product liability claims involving a spinal cord s...

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Human Drugs

Ashley Retiring as CDER Compliance Director

FDA announces the retirement of CDER Office of Compliance director Don Ashley.

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Human Drugs

FDA Looking at Marijuana Scheduling Flexibility: Woodcock

FDA principal deputy commissioner Janet Woodcock says the agency is exploring what flexibility it has in reviewing the science and health benefits of ...

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Federal Register

EUA Granted for Abbott Monkeypox Diagnostic

Federal Register notice: FDA announces an Emergency Use Authorization for Abbott Molecular and its Alinity m MPXV monkeypox diagnostic test.

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Human Drugs

Guide on C-diff Infection Drug Development

FDA makes available a draft guidance entitled Clostridioides difficile Infection (CDI): Developing Drugs for Treatment, Reduction of Recurrence, and P...