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FDA Clears OB-Tools Fetal Heart Monitor

[ Price : $8.95]

FDA clears an OB-Tools 510(k) for its fetal heart rate monitoring unit, which is integrated into its TrueLabor maternal fetal moni...

Jazz NDA for Defibrotide Accepted for Priority Review

[ Price : $8.95]

FDA accepts for priority review a Jazz Pharmaceuticals NDA for defibrotide, indicated for treating patients with hepatic veno-occl...

FDA Concerns About Chinese Drugs Detailed

[ Price : $8.95]

Bloomberg News reports that FDA is trying to increase drug company inspections in China to ensure the quality of finished drugs an...

FDA Extends NDA Review for Newrons Parkinsons Drug

[ Price : $8.95]

FDA extends by three months its review of a Newron Pharmaceuticals NDA for Xadago (safinamide), indicated as add-on therapy in bot...

FDA Seeks Participants for Biosimilar Act Reauthorization

[ Price : $8.95]

Federal Register Notice: FDA request that drug companies and trade associations notify the agency of an intent to participate in t...

Medtronic PMA Approved for Bladder/Bowel Evaluations

[ Price : $8.95]

FDA approves a Medtronic PMA for the Verify Evaluation System for use in making basic bladder/bowel evaluations, which last up to ...

FDA Social Media Rules Violate 1st Amendment: WLF

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Washington Legal Foundation says FDA should consider that a successful First Amendment challenge is likely against its social medi...

Pew Warns Against Expanding Animal Antibiotic OKs

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The Pew Charitable Trusts says FDA should not expand conditional approvals for antibiotics beyond minor species or minor uses in m...

What Does 510(k) Clearance Show at Trial on Safety?

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Attorney John Sullivan questions a courts decision to allow trial testimony on a Boston Scientific 510(k) clearance, but with a ve...

QS, MDR Violations Found in Ultroid Inspection

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FDAs Florida District Office warns Ultroid Technologies about QS and MDR violations in its manufacturing of a misbranded hemorrhoi...