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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 ...

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...

FDA Restricting Industry Reps on Advisory Committees

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FDA commissioner Marty Makary announces a new policy directive that limits those employed at regulated industries from serving as ...

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...

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...