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NIH Funds Biomed Tech Hubs

[ Price : $8.95]

The National Institutes of Health awards $29 million to fund five additional Research Evaluation and Commercialization Hubs to spe...

Merck Seeks to Expand Dificid Labeled Use

[ Price : $8.95]

FDA accepts for priority review a Merck NDA for Dificid (fidaxomicin) for oral suspension, and a supplemental NDA for a new indica...

Puma Biotech Labeling Supplement for Nerlynx

[ Price : $8.95]

FDA approves a Puma Biotechnology labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive...

24 Drugs not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that 24 drug products were not withdrawn due to safety or effectiveness reasons.

Panel Mulls Immune Responses with Metal Devices

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Federal Register notice: FDA announces an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting to d...

Draft Guide on Patient-focused Drug Development

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Federal Register notice: FDA makes available a draft guidance on Patient-Focused Drug Development: Methods To Identify What Is Imp...

CGMP Violations at South Koreas Dermameal

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FDA warns South Koreas Dermameal about CGMP violations in its role as a contract manufacturer of finished pharmaceuticals.

$220 Million Sentinel Next Phase Contract Awarded

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FDA awards a five-year contract that could be worth $220 million to Harvard Pilgrim Health Care Institute for the next phase of th...

FDA Explains Urgent/11 Cybersecurity Vulnerability

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FDA provides information about the Urgent/11 cybersecurity vulnerability that could affect medical devices.

Endo Claims Win in Vasopressin Compounding Case

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Endo says it is withdrawing a 2017 suit against FDA over agency enforcement discretion in permitting bulk drug compounding of vaso...