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FDA Update on Ranitidine Contaminant Testing

[ Price : $8.95]

FDA says it is continuing to test ranitidine products from multiple manufacturers and is assessing the potential impact on patient...

Guide on Testing Blood for Hep C

[ Price : $8.95]

FDA makes available a final guidance entitled Further Testing of Donations that are Reactive on a Licensed Donor Screening Test fo...

Enzyme Replacement Therapy Guidance

[ Price : $8.95]

FDA issues a guidance to help sponsors develop and conduct nonclinical studies during development of investigational enzyme replac...

Turner Portable Fluoroscopy/X-Ray Device Cleared

[ Price : $8.95]

FDA clears a Turner Imaging Systems 510(k) for its Smart-C Mini-C Arm Portable Fluoroscopy and X-Ray Imaging Device.

GSK, Innoviva sNDA for Trelegy Ellipta in Asthma

[ Price : $8.95]

GlaxoSmithKline and Innoviva submits a supplemental NDA seeking an additional indication for once-daily use of Trelegy Ellipta for...

J&J Settles Ohio Opioid Cases for $20.4 Million

[ Price : $8.95]

Reuters reports that Johnson & Johnson will pay two Ohio counties $20.4 million to resolve opioid crisis claims.

IMDRF Draft Cybersecurity Guidance

[ Price : $8.95]

The International Medical Device Regulators Forum publishes a draft medical device cybersecurity guidance.

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...