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CDER says it is receiving reports from healthcare professionals about ongoing difficulties with the Clozapine REMS Program, includ...[ Price : $8.95]
FDA posts a guidance on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Cou...[ Price : $8.95]
FDA releases a draft guidance on Class II Special Controls Guideline: In Vitro Diagnostic Devices for Bacillus spp. Detection.[ Price : $8.95]
Federal Register Notice: FDA is making available a guidance for industry entitled Guidance on Qualification of Biomarker Galactom...[ Price : $8.95]
FDA classifies as Class 1 a Hamilton recalls of its G5 Ventilators because of ventilation and alarm failures.[ Price : $8.95]
The Alliance for a Stronger FDA urges a letter writing campaign from its members to prod Capitol Hill appropriators to increase th...[ Price : $8.95]
FDA clears a Spectranetics 510(k) for its Turbo-Power Laser Atherectomy Catheter and its use in treating in-stent restenosis.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a collection of information on the reporting of harmful constituents in tobacco pro...