$2.7m spend by FDA

PPD, Inc. 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 Initiative for Maximizing the Benefit of Passive Adverse Event Collection throughout a Product’s Life Cycle (IMPACT). IMPACT, launched in 2008, is intended to fulfill a Prescription Drug User Fee Act (PDUFA) IV commitment.