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Effective Nonconformance Management Key To FDA And ISO Compliance

2013-09-05 02:46:37| drugdiscoveryonline Downloads

A product’s quality, reliability, and safety depend to a great extent on its conformance to specifications that have been tested, proven safe, and approved.

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Mercks Durham Site Receives U.S. FDA Licensure for Varicella Bulk

2013-09-04 21:50:12| Merck.com - Corporate News

Dateline City: DURHAM, N.C. Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture bulk varicella at the companys site in Durham, N.C., for use in Mercks vaccines to protect against chickenpox and shingles. The approval will enable the site to produce bulk varicella supply for the U.S. and help boost Mercks overall global supply capabilities. In 2010, the site was approved to produce finished chickenpox vaccines. Language: English Ticker Slug: Ticker: MRK Exchange: NYSE read more

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Sonendo® Receives 510(k) FDA Clearance for Its Multisonic Ultracleaning System(TM)

2013-09-03 06:00:00| Industrial Newsroom - All News for Today

System Designed to Improve Clinical Quality and Business Performance of Root Canal Therapy<br /> <br /> LAGUNA HILLS, Calif. - Sonendo®, the developer of a revolutionary technology for the endodontic marketplace, announced today that the company has received 510(k) FDA clearance for the first generation of its Multisonic Ultracleaning System&trade; set to launch in 2014.  The device is designed to be a minimally invasive, disruptive technology that uses multiple wavelengths of sound to ...This story is related to the following:Dental Equipment, Supplies & Tools

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FDA Announces New Pilot Regarding Drug Imports

2013-08-20 10:00:00| Expeditors Newsflash - Americas Edition

Expeditors Newsflash - Americas Edition

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New 4-strain flu vaccine gets FDA approval

2013-08-18 12:54:36| Biotech - Topix.net

People for the first time will have the option of getting inoculated against the flu with a newly developed 4-strain vaccine rather than the 3-strain vaccine that's been in use for decades.

Tags: approval flu fda vaccine

 

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