Booz Allen Hamilton gets FDA bid to assess post-marketing study commitments

By Elaine Rigoli

Tampa, Fla., April 6 - The Food and Drug Administration has awarded a contract to Booz Allen Hamilton to conduct a thorough evaluation of the post-marketing study commitment process for collecting medical information.

The goal of this in-depth examination is greater internal consistency and a more standardized approach across the medical centers at the FDA for requiring, requesting, facilitating and reviewing post-marketing study commitments.

Post-marketing study commitments, also called phase 4 commitments, are studies conducted after the FDA has approved a product for marketing that a sponsor is required, or has agreed, to conduct.

These studies help to complete the medical community's knowledge concerning the best use of a product because these studies are intended to further define the safety, efficacy or optimal use of a product, according to a news release.

Over the next year, Booz Allen Hamilton will examine the agency's internal processes and make recommendations regarding ways to improve processes and practices, the release said.

The evaluation is scheduled to begin in April and is expected to take about 12 months to complete.

Booz Allen Hamilton is a private consulting company with corporate headquarters in McLean, Va.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.