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ICU Medical Illegally Marketing Devices: FDA

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FDA warns ICU Medical that its Minneapolis, MN-based Smiths Medical ASD unit is illegally marketing adulterated and misbranded inf...

CDER Continues Quality Management Program

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Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second year of its voluntary Quality Ma...

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 ...

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...