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CDRH Proposing 11 Guidances for FY 2026

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CDRH releases a list of 11 final and draft guidances it plans to issue in FY 2026 if resources permit.

Makary Outlines Mission Critical Ops Under Shutdown

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FDA commissioner Marty Makary tells employees affected by the government shutdown that the agency will continue mission-critical a...

AbbVie BLA for Treating Rare Blood Cancer

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AbbVie files a BLA seeking approval for its investigational antibody-drug conjugate pivekimab sunirine to treat blastic plasmacyto...

WLF Wants End to FDA TV Ad Crackdown

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The Washington Legal Foundation calls on the FDA to stop its broad crackdown on drug TV advertising, citing First Amendment protec...

FY 2026 GDUFA Science and Research Priorities

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FDA releases a list of eight Generic Drug User Fee Act science and research priorities for FY 2026, covering 23 separate initiativ...

FDA Clears New Version of UroViu Endoscope

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FDA clears a UroViu 510(k) for its UV5000 cordless, single-use endoscope platform.

No IND Submitted for Study

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FDA warns San Francisco, CA-based dentist Pamela Den Besten about conducting a clinical trial on an investigational drug without a...

Multiple Violations at Persōn & Covey

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FDA warns Glendale, CA-based Persōn & Covey about CGMP violations in its production of unapproved drugs.

CDER Head Targets Surrogate Endpoints, Lupus Drug

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In an unprecedented LinkedIn post, CDER director George Tidmarsh questions the use of surrogate endpoints and publicly attacks Aur...

Quantitative Medicine CoE Progress Update

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The CDER Quantitative Medicine Center of Excellence issues a report on goals and accomplishments in the first 16 months of its exi...