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FDA General

FDA Commissioner Outlines Ambitious Vision for Breakthrough Treatments

FDA commissioner Marty Makary shares his expansive vision for future medical breakthroughs, telling agency staff he hopes to see transformative treatm...

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Human Drugs

October Deadline for New Adverse Event Reporting Standard

FDA says beginning 10/1 it will require drugmakers and other regulated entities to adopt updated international data standards for submitting postmarke...

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Human Drugs

Context Therapeutics Ovarian Cancer Drug Wins Fast Track

FDA grants Context Therapeutics a fast-track designation for its experimental therapy CTIM-76 for treating platinum-resistant ovarian cancer.

FDA General

HHS Weighs Reversal of FDA Peptide Restrictions Despite Safety Concerns

HHS is considering reversing a 2023 FDA decision that deemed a group of peptide drugs too risky for use by compounding pharmacies, a move that has spa...

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Biologics

CBER File Over Protest SOPP

CBER publishes a Standard Operating Policy and Procedure on filing an application over protest after a Center refusal-to-file decision.

Medical Devices

FDA Expanding Real-World Evidence Use in Device Regulation

CDRH leaders describe efforts to expand the use of real-world evidence in a range of medical device regulatory activities.

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Human Drugs

FDA Enforcement Discretion for Some Hemp CBD Products

FDA says it will exercise enforcement discretion and not enforce specific sections of the Federal Food, Drug, and Cosmetic Act as they apply to hemp-d...

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Human Drugs

Trump Plans New Tariffs on Pharmaceutical Industry

President Trump prepares to impose sweeping new tariffs on certain pharmaceutical imports, targeting companies that have not agreed to participate in ...

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Medical Devices

FDA Denies CAD/CADt Device 510(k) Exemption Petition

FDA denies a petition seeking a partial exemption of 510(k) requirements for some specific radiology computer-aided detection and/or diagnosis devices...

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Human Drugs

Bipartisan Senators Urge FDA to Pre-Screen Certain Drug Ads

Two bipartisan senators press FDA to take a more proactive role in policing prescription drug advertising, citing a surge in misleading direct-to-cons...