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Panel to Discuss Bulk Drug Substance Nominees

[ Price : $8.95]

Federal Register Notice: FDAs Pharmacy Compounding Advisory Committee will meet 10/27-28 to discuss ten bulk drug substances nomin...

Questionable Results for Priority Review Vouchers: Study

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

Cardiac Ablation Remote into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies the steerable cardiac ablation catheter remote control system into Class 2.

Guidance on Veterinary Feed Directive Q&A

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Federal Register Notice: FDA releases a small entity compliance guide and guidance entitled Veterinary Feed Directive Regulation Q...

Orphan Status for Blueprint Medicine Liver Cancer Therapy

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FDA grants Blueprint Medicines an orphan drug designation for BLU-554 for treating hepatocellular carcinoma.

FDA Clears OB-Tools Fetal Heart Monitor

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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

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

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...

FDA Concerns About Chinese Drugs Detailed

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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

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