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FDA Clears HeartFlows Blood Flow Analyzer Software

[ Price : $8.95]

FDA approves a de novo petition to allow the marketing of HeartFlows FFR-CT software, which permits health care professionals to e...

FDA Binding Recommendations Urged for Clinical Trials

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Dartmouth Institute for Health Policy and Clinical Practice researchers say one way to achieve higher quality drug approvals is to...

FDA Draft Guidance on Drug Product Tracing Information

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FDA posts a draft guidance on statute-required Standards for the Interoperable Exchange of Information for Tracing of Certain Huma...

FDA Warning for OTC Acetaminophen Products

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FDA publishes a draft guidance with a recommended label warning for OTC acetaminophen-containing products on the potential for ser...

NEWSROOM CLOSED FOR THANKSGIVING

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FDA Webview has closed its newsroom to observe the Thanksgiving holiday in the U.S. Our next overnight email bulletin will be issu...

FDA Wants More Data on BMS Hepatitis C Drug

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FDA issues Bristol-Myers Squibb a complete response letter on its NDA for daclatasvir, an NS5A complex inhibitor for use in combin...

FDA Accepts Revive Therapeutics Gout Treatment IND

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FDA accepts Revive Therapeutics IND for bucillamine as a potential new gout treatment.

Dr. Reddys to Respond to FDA Inspection

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Indias Dr. Reddys says it will immediately implement remediations called for in a recent FDA inspection at its active pharmaceutic...

Grifols Gains FDA Approval for Plasma Production Facility

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FDA approves Grifols new plasma facility in Clayton, NC and will begin production next year.

FDA Faults Hospital for Morcellator Use without IDE

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CDRH deputy director for science William Maisel criticizes a Brigham and Womens Hospital clinical study for using now-restricted l...