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Review Period Determined for Giapreza

[ Price : $8.95]

Federal Register notice: FDA determines the regulatory review period for La Jolla Pharmaceuticals Giapreza (angiotensin II).

Guide on Pediatric Partial Onset Seizures

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Drugs for Treatment of Partial Onset Seizures: Full Extrapo...

Info Collection Extension for GCP Guide

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Guidance for Industry on E6 (R2) Good Clini...

Bardy Diagnostic 14-day P-wave Monitor Cleared

[ Price : $8.95]

FDA clears a Bardy Diagnostics 510(k) for its 14-Day version of the Carnation Ambulatory Monitor, a P-wave heart monitor.

Endo BLA for Treating Buttock Cellulite

[ Price : $8.95]

Endo International files a BLA for collagenase clostridium histolyticum for treating cellulite in the buttocks.

Woodcock Sees Addiction as Top Public Health Threat

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CDER director Janet Woodcock says addiction currently is the most serious threat to public health.

FDA OKs Boehringer Lung Disease Drug

[ Price : $8.95]

FDA approves Boehringer Ingelheim Pharmaceuticals Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in ...

FDA Wants Weight Loss Device Feedback

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FDA seeks comment on a discussion paper on how to determine and consider benefit and risk in weight-loss medical devices.

Seizure Drug Efficacy Extrapolation Guidance

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FDA issues a guidance on clinical development of drugs to treat partial onset seizures in pediatric patients over age two.

2 Humanitarian Use Guidances

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FDA publishes two guidances relating to humanitarian use device designations and humanitarian device exemptions.