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IDE Approved for StimRelieve Trial of Pain Device

[ Price : $8.95]

FDA approves a StimRelieve IDE for the company to launch a clinical trial of what it describes as the worlds smallest percutaneous...

Bayer Asks FDA for Stricter BE Requirements for Mirena

[ Price : $8.95]

Bayer petitions FDA asking that it institute strict bioequivalence requirements before approving any ANDA for a generic copy of it...

Workshop on Device Cybersecurity

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 1/20-21/16 entitled: Moving Forward: Collaborative Approaches to Medical Devi...

Group Asks FDA Not to Approve Gout Drug

[ Price : $8.95]

Public Citizen urges FDA not to approve AstraZenecas lesinurad oral tablets for treating hyperuricemia associated with gout becaus...

Laguna Pharma Shuts Down Due to Failed Drug

[ Price : $8.95]

Start-up Laguna Pharmaceuticals shuts down following disappointing Phase 3 clinical trial results involving its lone drug candidat...

eVent Recalls Faulty Inspiration Ventilators

[ Price : $8.95]

eVent Medical begins a Class 1 recall of its LS, 5i, and 7i Inspiration Ventilators because they may shut down without an alarm so...

Adamis Pharma Resubmits NDA on Epinephrine Syringe

[ Price : $8.95]

Adamis Pharmaceuticals refiles an NDA for its epinephrine pre-filled syringe product for the emergency treatment of anaphylaxis.

Keep FDAs Hands Off Mobile Health Apps: Gottlieb

[ Price : $8.95]

American Enterprise Institute scholar and former FDA deputy commissioner Scott Gottlieb says the government should put a different...

Recent Advisory Committee Trends Detailed in Report

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A new report from Avalere Health on advisory committee trends finds that CDERs Cardiovascular and Renal Drugs Committee has recomm...

FDA Requires New Warning on Diabetes Drugs

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An FDA drug safety review leads to warnings being added to Type 2 diabetes drugs called sodium-glucose cotransporter-2 inhibitors ...