Health

FDA awards contract to evaluate postmarketing study system

NEWS IN BRIEF — Posted May 8, 2006

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The Food and Drug Administration has awarded a contract to Booz Allen Hamilton, a global strategy and technology consulting firm, to evaluate the process for devising and completing postmarketing study commitments, according to a statement issued by the agency last month.

Postmarketing study commitments are often garnered from companies as part of the approval process for drugs and biologics. This action was taken because of the growing recognition that these studies are vital but frequently left undone.

"Even the largest and best designed premarket studies cannot reasonably answer all of the important questions that may arise about medicines," said Steven Galson, MD, director of the FDA's Center for Drug Evaluation and Research.

The FDA hopes that this review will result in a greater consistency in requirements between the agency's different centers and improvements in the overall process that will lead to more of these studies being completed in a timely manner.

The evaluation begins this month and is expected to take a year.

Note: This item originally appeared at http://www.ama-assn.org/amednews/2006/05/08/hlbf0508.htm.

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