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EtQ Incorporates Biometrics to its 21 CFR Part 11 Electronic Signature Functionality
EtQ has developed the ability for 3rd party Biometric readers to authenticate 21 CFR Part 11 electronic signatures within the EtQ Reliance FDA Complia...

FDA Grants Fast Track Status For HCV-796 For Treatment Of Hepatitis C Virus Infection
ViroPharma announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for HCV-796 for treatment of hepatitis C viru...

FDA Priority Review Granted for ISENTRESS, Merck's Investigational Integrase Inhibitor for HIV
Merck & Co.announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ISENTRESS (raltegravir, previous...

Taxotere Granted FDA Priority Review For Treatment Of Locally Advanced Squamous Cell Carcinoma Of The Head And Neck
Sanofi-aventis announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and assigned priority review status to the supplemen...

Shelhigh and FDA Reach an Agreement
Shelhigh announced that it has reached a no-fault settlement agreement with the U.S. Food and Drug Administration (FDA) that provides a clear path to ...

FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone
Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted, for filing and review, the New Drug Application (NDA) fo...

FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension
The U.S. Food and Drug Administration (FDA) approved Letairis (ambrisentan) for the treatment of pulmonary arterial hypertension, a rare, life-threate...

FDA Releases New Software Tool to Help Keep Food Facilities Safe from Attack
The U.S. Food and Drug Administration (FDA) released a new tool to help growers, packers, processors, manufacturers, warehousers, transporters, and re...

FDA Clearance For World's First RFID Surgical Sponge Counting System To Prevent Retention Of Surgical Sponges
ClearCount Medical Solutions, a Pittsburgh-based company focused on developing smarter solutions to improve patient safety inside the operating room, ...

FDA Implementing Initiative To Reduce Tomato-Related Foodborne Illnesses
he U.S. Food and Drug Administration (FDA) will begin a multi-year Tomato Safety Initiative, to reduce the incidence of tomato-related foodborne ill...

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