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Hearings for Nitroglycerin in Transdermal Systems Withdrawn

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Federal Register Notice: FDA announces that all outstanding hearing requests on nitroglycerin drug products in transdermal systems...

FDA Plans Sentinel Initiative Public Workshop

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Federal Register Notice: FDA plans a public workshop 2/3/16: Eighth Annual Sentinel Initiative Public Workshop.

Nominations Sought for Tobacco Scientific Panel

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Federal Register Notice: FDA requests nominations for its Tobacco Products Scientific Advisory Committee.

Janssen Multiple Myeloma Drug Given Accelerated Approval

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FDA grants accelerated approval to a Janssen Biotech NDA for Darzalex (daratumumab) for treating patients with multiple myeloma wh...

Should FDA Move to European Model for Approving Devices/Drugs?

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An opinion piece by a former FDA official in the Charleston Gazette-Mail says the U.S. would be better served if it moved more tow...

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Draft Guidance on IVDs for Bacillus spp.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FDA releases a draft guidance on Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp.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

FDA Corrects Final Rule on Tobacco Product Marketing

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Federal Register Notice: FDA corrects certain reference numbers in the preamble to a 9/24 final rule on environmental assessments ...

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...