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FDA Enforcement Discretion for Some Hemp CBD Products

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FDA says it will exercise enforcement discretion and not enforce specific sections of the Federal Food, Drug, and Cosmetic Act as ...

Trump Plans New Tariffs on Pharmaceutical Industry

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

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

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

Bipartisan Senators Urge FDA to Pre-Screen Certain Drug Ads

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

FDA Accepts Ultragenyx Resubmission for Gene Therapy

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Ultragenyx Pharmaceutical refiles a BLA seeking accelerated approval for UX111, an AAV9 gene therapy for the treatment of Sanfilip...

Makary Signals Push for Faster Approvals, and Sweeping Reforms

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

Kites Tecartus for Mantle Cell Lymphoma Gets Full Approval

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

New CBER Head Should Restore Rare Disease Clarity: Advocates

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

Multiple Violations at LeeSar Outsourcing Facility

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An FDA untitled letter cautions the Fort Myers, FL-based LeeSar drug outsourcing facility about CGMP and other violations in its p...

Multiple Violations in Physitemp Instruments Inspection

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FDA warns Clifton, NJ-based Physitemp Instruments about Quality System, Medical Device Reporting, Unapproved Device, and Unique De...