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FDA Integrity, Decision-Making at Risk: Blog

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FDA Matters founder Steven Grossman says FDA commissioner Martin Makary and the Trump administration are at a crossroads and need ...

ICH Q1 Stability Testing Guide Out for Comment

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The International Council for Harmonization endorses and releases for comment its Q1 guidance on drug product stability testing.

FDA Alert on Compounded Topical Finasteride

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FDA says it has received reports of adverse effects associated with using unapproved compounded topical finasteride products.

Drug Promotion Leaders Leave Agency

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FDA Office of Prescription Drug Promotion director Catherine Gray and deputy director Mark Askine resign their posts in the wake ...

AI in Regulatory Science: Conference Report

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A report on the 2024 Global Summit on Regulatory Science calls for a collaborative global effort to harness artificial intelligenc...

FDA 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...

Bard Recalls BD 4 Fr. PowerPICC Catheters

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Bard Access Systems recalls its BD 4 Fr. Single Lumen PowerPICC Catheters due to tubing that exceeded melt flow index specificatio...

QApel Recalls Aspitration System

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QApel Medical recalls and discontinues the marketing of its 072 Aspiration System (also known under the product name Hippo and Che...

Rare Disease Drug Development Articles

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Researchers publish two journal articles relating to rare disease drug development.

Panel on Opioid Overdose Studies

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Federal Register notice: FDA reschedules a previously planned drug safety advisory committee involving opioid overdose risk studie...