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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 ...

QS Violations at Noah Medical Corporation

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FDA warns San Jose, CA-based Noah Medical about Quality System violations in its manufacturing of the Galaxy System bronchoscopes ...

Promising Enhertu+Perjeta Data in Breast Cancer

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AstraZeneca and Daiichi Sankyo report interim data from a Phase 3 trial that showed Enhertu (trastuzumab deruxtecan), in combinati...

Lt. Governors Urge Trump to Support FDA, Other Agencies

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The Democratic Lieutenant Governors Association writes president Donald Trump urging him to support and safeguard the integrity of...

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...