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FDA Clears Spectranetics Laser Atherectomy Catheter

[ Price : $8.95]

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...

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.

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...

Accelerated Approval for AstraZeneca Lung Cancer Drug

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FDA grants accelerated approval for an AstraZeneca NDA for Tagrisso (osimertinib), an oral medication to treat patients with advan...

Petition Seeks Removal of Phenylephrine from Monograph

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A citizen petition urges FDA to issue a final rule removing oral phenylephrine from the Final Monograph for Over-the-counter Nasal...

FDA Orders Recall of Endoscope Cleaners Under Decree

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FDA orders Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) due to its continued violations of a 20...

FDA Clears Perspectum Diagnostics LiverMultiScan

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FDA clears a Perspectum Diagnostics 510(k) for the LiverMultiScan imaging device, which is intended to detect early liver disease ...