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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.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a collection of information on the reporting of harmful constituents in tobacco pro...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America says it supports FDAs proposed naming policy that calls for biological produc...[ 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]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on dietary supple...[ Price : $8.95]
FDA grants accelerated approval for an AstraZeneca NDA for Tagrisso (osimertinib), an oral medication to treat patients with advan...[ Price : $8.95]
A citizen petition urges FDA to issue a final rule removing oral phenylephrine from the Final Monograph for Over-the-counter Nasal...