FDA Post-Marketing Studies Process to Be Reviewed
Posted on: Thursday, 6 April 2006, 15:00 CDT
The FDA has awarded a contract to consulting firm Booz Allen Hamilton to conduct a thorough evaluation of the post-marketing study commitment process for collecting medical information. The goal of this examination is to achieve greater internal consistency across the FDA's medical centers for requesting, facilitating and reviewing phase IV studies.
Post-marketing study commitments (PMCs), also called phase IV 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 the studies are intended to further define the safety, efficacy, or optimal use of a product.
The FDA said that it fully intends to work with sponsors to make sure these studies 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 the agency's internal processes regarding PMCs and make recommendations regarding ways to improve PMC processes and practices.
This assessment, the regulator hopes, will ultimately lead to greater internal consistency across the FDA's medical product centers.
The evaluation is scheduled to begin in April and is expected to take approximately 12 months to complete.
Source: Datamonitor
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