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Jazz Pharma Petitions FDA on Generic Xyrem Concerns

[ Price : $8.95]

A Jazz Pharmaceuticals citizen petition asks FDA not to approve any generic applications that reference its Xyrem (sodium oxybate)...

Emmaus Files NDA for Sickle Cell Drug

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Emmaus Life Sciences files an NDA for its orally administered pharmaceutical grade L-glutamine (PGLG) for treating sickle cell dis...

FDA Clears Carestream 3D Extremity Scan System

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FDA clears a Carestream 510(k) for the OnSight 3D Extremity System, which uses cone beam computed tomography technology to capture...

United Exchange Recalls Contaminated Eye Wash

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United Exchange Corp. recalls five lots of its Family Care Eye Wash due to microbial contamination.

FDA Posts ICH Guide on Multi-regional Trials

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FDA posts an International Conference on Harmonization draft guidance on General Principles for Planning and Design of Multi-Regio...

Info On Postmarket Surveillance Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on postmarket surveillance to the Office of Management a...

Comments Sought on Device Recordkeeping Requirements

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Federal Register Notice: FDA seeks comments on recordkeeping requirements in Medical Devices: Current Good Manufacturing Practice ...

FDA Renews Oncologic Drugs Panel

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Federal Register Notice: FDA renews the charter of the Oncologic Drugs Advisory Committee.

Prevacid IV Not Withdrawn For S&E

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Federal Register Notice: FDA determines that Prevacid IV intravenous 30 mg/vial was not withdrawn from sale for reasons of safety ...

10 Recommendations to Transform Cancer

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The Cancer Moonshot Blue Ribbon Panel publishes a report with 10 recommendations for research that could change the course of canc...