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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...

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FDA General

Makary Signals Push for Faster Approvals, and Sweeping Reforms

In a wide-ranging 4/1 address to employees at FDA, commissioner Marty Makary outlines an expansive agenda to accelerate drug approvals, lower costs, a...

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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 ...

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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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

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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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.

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Biologics

Kites Tecartus for Mantle Cell Lymphoma Gets Full Approval

FDA grants full approval for Kites CAR-T cell therapy Tecartus (brexucabtagene autoleucel) for adult patients with relapsed or refractory mantle cell ...

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Biologics

FDA Accepts Ultragenyx Resubmission for Gene Therapy

Ultragenyx Pharmaceutical refiles a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilippo syndrome Type A....

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Human Drugs

New CBER Head Should Restore Rare Disease Clarity: Advocates

A rare disease coalition calls on the Trump administration to appoint a new CBER director who understands rare disease drug development and values the...