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Insys Therapeutics Sales Manager Debarred

[ Price : $8.95]

Federal Register notice: FDA issues an order to permanently debar former Insys Therapeutics regional sales manager Sunrise Lee.

RedHill Bio Fast Track for Antibacterial

[ Price : $8.95]

FDA grants RedHill Biopharma a fast track designation for RHB-204 and its use as a potential first-line, stand-alone, oral treatme...

Brain Therapy for Alzheimers Breakthrough Status

[ Price : $8.95]

FDA grants Functional Neuromodulation a breakthrough device designation for the Vercise Deep Brain Stimulation System for treating...

Tidepool 510(k) for iPhone Insulin Dosing App

[ Price : $8.95]

Tidepool files a 510(k) for an automated insulin dosing app for use on the iPhone for managing Type 1 diabetes.

FDA Joining Pathology Innovation Collaborative Community

[ Price : $8.95]

MDIC says FDA is joining its new Pathology Innovation Collaborative Community.

Guide on Device Safer Technologies Program

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Safer Technologies Program for Medical Devices.

Gene Therapy for Neurodegenerative Diseases Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Human Gene Therapy for Neurodegenerative Diseases.

Teva Raises BA/BE Retention Sample Compliance Policy Concerns

[ Price : $8.95]

Teva raises concerns with an FDA compliance policy on bioavailability and bioequivalence samples to be retained.

Comments on FDA REMS Summary Posting Proposal

[ Price : $8.95]

Stakeholders recommend ways to improve the effectiveness of FDAs proposed posting of REMS summaries.

Priority Review for AstraZenecas Farxiga for Kidney Disease

[ Price : $8.95]

FDA grants priority review to AstraZenecas Farxiga to treat patients with chronic kidney disease with and without Type 2 diabetes....