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Prescription Drug User Fee Rates Set

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Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2025.

Amco Illegally Selling AED Batteries: FDA

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FDA warns Brooklyn, NY-based Amco International Manufacturing & Design about illegally manufacturing and distributing adulterated ...

OSE Involved in 55 Novel Drug Approvals

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The CDER Office of Surveillance and Epidemiology annual report says it contributed to 55 novel drug and therapeutic biologic appro...

Vertex NDA for Pain Drug Accepted for Review

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FDA accepts for review a Vertex Pharmaceuticals NDA for suzetrigine, a selective NaV1.8 pain signal inhibitor for treating moderat...

Generic Drug User Fee Rates for FY 2025

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Federal Register notice: FDA releases fiscal year 2025 rates for generic drug user fees.

FDA Clears Varian Microwave Ablation

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FDA clears a Varian 510(k) for its IntelliBlate microwave ablation system, intended for ablating soft tissue.

Require Nasal Spray Food Studies: Aquestive

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Aquestive asks FDA not to approve any nasal sprays that do not submit food effect studies as part of their application.

Amazon, Walmart Illegally Sell Chemical Peels

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FDA warns Amazon and Walmart they are introducing unapproved chemical peel products into interstate commerce.

FDA Denies Public Citizen Tramadol Petition

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Citing a lack of legal authority, FDA denies a Public Citizen 2019 petition asking it to join with the Drug Enforcement Administra...

Novartis sNDA for Scemblix Expanded Use

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FDA accepts for priority review a Novartis supplemental NDA for Scemblix (asciminib) for the drugs expanded use in treating newly ...