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FDA OKs Medtronics Valiant Captivia Stent for Aortic Injuries

[ Price : $8.95]

FDA approves Medtronics Valiant Captivia stent graft system for repairing blunt traumatic aortic injuries.

QS Violations Found in Westone Labs Inspection

[ Price : $8.95]

FDAs Denver District Office warns Westone Laboratories about QS violations in its manufacturing of the Oto-Ease patient lubricant....

FDA Accepts Geno NDA for Nitric Oxide System

[ Price : $8.95]

FDA accepts for review a GeNO LLC NDA for GeNOsyl MVG-2000 Nitric Oxide Delivery System for neonates with hypoxic respiratory fail...

Some Whistleblower Records Properly Withheld: Court

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A DC federal court rules that HHS acted properly in redacting and withholding some documents sought by CDRH whistleblowers.

Academic Groups Air Biosimilar Patent Concern

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Leaders of six higher education associations ask FDA for a requirement that biosimilar applicants certify their compliance with th...

Reviewers Say Dynavax Hep B Vaccine is Effective

[ Price : $8.95]

CBER clinical reviewers tell the Vaccines and Related Biological Products Advisory Committee that Dynavax Technologies Heplisav ap...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites The Avalon Effect, Health Breakthroughs, I. Shay Cosmetics, Mushroon Wisdom, and...

Microgenics FDA-483 Posted for June Inspection

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A June FDA inspection of Microgenics Fremont, CA facility cites the firm for failing to adequately investigate complaints related ...

Paragonix Files 510(k) for Heart Transplant Storage

[ Price : $8.95]

Paragonix Technologies files a Sherpa Pak Cardiac Transport System, intended for static hypothermic preservation of hearts during ...

Mixed Vote on Merck OTC Overactive Bladder Patch

[ Price : $8.95]

FDAs Nonprescription Drugs Advisory Committee delivers a mixed vote for a Merck proposal to market an over-the counter version of ...