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Bulletproof Your Business
This technology brief describes how, for the overwhelming majority of companies today, the question is no longer whether they need a good business con...

Data Breaches Are Frequent, but Evidence of Resulting Identity Theft Is Limited; However, the Full Extent Is Unknown
While comprehensive data do not exist, available evidence suggests that breaches of sensitive personal information have occurred frequently and under ...

FDA Center for Drug Evaluation and Research: Drug Master Files transferred from CBER
This site contains lists of Drug Master Files (DMFs) as well as information concerning submission of DMFs.

FDA Device Advice: Good Manufacturing Practices (GMP) / Quality System (QS) Regulation
The current Good Manufacturing Practice (GMP) requirements set forth in the Quality System (QS) regulation are promulgated under section 520 of the Fo...

Glaxo confident as FDA probes asthma drugs in kids
The safety of GlaxoSmithKline Plc's top-selling asthma drugs Serevent and Advair is back in the spotlight this week as a U.S. regulatory panel meets t...

Greater Harm Than Good?
The use of diagnostic ultrasound in pregnancy is well established. Although the patterns of use vary from country to country and region to region, the...

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