Contract News

FDA Awards Contract to Assess Decision-Making Process

The Food and Drug Administration (FDA) has awarded a contract to Booz Allen Hamilton to conduct a thorough evaluation of the postmarketing study commitment process for collecting medical information. The goal of this in-depth examination is greater internal consistency across the medical Centers at FDA for requiring, requesting, facilitating, and reviewing postmarketing study commitments.

Postmarketing study commitments, also called Phase 4 commitments, are studies conducted after FDA has approved a product for marketing that a sponsor is required, or has agreed, to conduct. These studies play a vital role in helping to complete the medical community’s knowledge concerning the best use of a product because these PMCs are intended to further define the safety, efficacy, or optimal use of a product.

“Even the largest and best designed pre-market studies cannot reasonably answer all of the important questions that may arise about medicines,” said Steven Galson, M.D., Director, Center for Drug Evaluation and Research. “Continuing to evaluate drugs after they are approved is an important part of ensuring their safety and learning new things about their benefits.” Read more at fda.gov

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