PPD to Evaluate US FDA Public Health Surveillance System

PPD has been awarded a contract by the US 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 an evaluation of the value of the spontaneous adverse event reports to support safety-related regulatory actions and will report its findings to the FDA and the public.

The award of US$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).

Under the contract, PPD will comprehensively evaluate this FDA public health surveillance system. First, the system will be described, including key objectives, components and the regulatory framework (eg, relevant laws).

The focus of the evaluation is the review and analysis of the system's role to support safety-related regulatory actions and the provision to FDA of a report. The report will detail study results, conclusions and recommendations for maximizing the system's ability to support safety-related regulatory actions for drugs and therapeutic biologics throughout a product's life cycle.