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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.”
FDA fully intends to work with sponsors to make sure these important commitments are properly focused, properly designed, and ultimately completed in an appropriate time frame to be of value to practitioners and patients. Over the next year Booz Allen Hamilton will examine in-depth the agency’s internal processes regarding PMCs and make recommendations regarding ways to improve our PMC processes and practices.
This assessment will ultimately lead to greater internal consistency across FDA’s medical product Centers, as the Centers require, request, facilitate, and review postmarketing study commitments for human drugs, biologic products, and medical devices. By strengthening the process for postmarketing study commitments, FDA is continuing to improve its regulation of new medical products by using the best management approaches, the best information technology, and the best quality systems and review processes.
The evaluation is scheduled to begin in April and is expected to take approximately 12 months to complete.
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