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Article: PPD Awarded U.S. Food and Drug Administration Contract to Evaluate FDA's Spontaneous Adverse Event Surveillance System.
- Article from:
- Business Wire
- Article date:
- October 27, 2009
CopyrightCOPYRIGHT 2009 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Providing drug safety and pharmacoepidemiology expertise to assist agency in fulfilling PDUFA IV commitment
WILMINGTON, N.C. -- PPD, Inc. (Nasdaq: PPDI) today announced it has been awarded a contract by the U.S. Food and Drug Administration (FDA) to evaluate the agency's Center for Drug Evaluation and Research (CDER) post-market spontaneous adverse event surveillance system. The company will conduct a thorough evaluation of the value of the spontaneous adverse event reports to support safety-related regulatory actions and report its findings to the FDA and the public.
The award of $2.7 million for year one, is part of a two-year project of FDA's ...