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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...

Digital Health Technologies an FDA Priority: Article

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Three FDA staffers discuss the agencys efforts to advance the use of digital health technologies in clinical trials.

Makary Says FDA Exploring Conditional Approvals

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FDA commissioner Marty Makary says the agency is exploring the use of a new drug approval pathway for rare diseases and incurable ...

Leaked Budget Document Projects FDA Cuts: Report

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An FDA Matters blog post analyzes a leaked document purporting to show a 17% decrease in FDA budget authority spending for FY 2026...

Urgent Steps to Counter Need for Chinese Drugs: Exiger

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Two reports highlight U.S. dependence on foreign sources for APIs and finished drugs and call for urgent steps to reduce that depe...