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CDER Reports Problems with Clozapine REMS Program

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CDER says it is receiving reports from healthcare professionals about ongoing difficulties with the Clozapine REMS Program, includ...

FDA Guidance on Acetaminophen Liver Warning Labeling

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FDA posts a guidance on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Cou...

Draft Guidance on IVDs for Bacillus spp. Detection

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FDA releases a draft guidance on Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection.

Guidance on Biomarkers in Treatments of Aspergillosis

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Federal Register Notice: FDA is making available a guidance for industry entitled Guidance on Qualification of Biomarker Galactom...

FDA Class 1 Recall Given to Ventilator Failures

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FDA classifies as Class 1 a Hamilton recalls of its G5 Ventilators because of ventilation and alarm failures.

Alliance for Stronger FDA Urges Budget Letter Campaign

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The Alliance for a Stronger FDA urges a letter writing campaign from its members to prod Capitol Hill appropriators to increase th...

FDA Clears Spectranetics Laser Atherectomy Catheter

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FDA clears a Spectranetics 510(k) for its Turbo-Power Laser Atherectomy Catheter and its use in treating in-stent restenosis.

Comments Sought on Harmful Tobacco Constituent Info

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Federal Register Notice: FDA seeks comments on a collection of information on the reporting of harmful constituents in tobacco pro...

PhRMA, GPhA Differ on FDA Naming Convention for Biosimilars

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Pharmaceutical Research and Manufacturers of America says it supports FDAs proposed naming policy that calls for biological produc...

FDA Sends Info on Supplement Labeling to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on dietary supple...