Neurologist

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Drug Information Update- FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. 

 

Makers of approved drugs and biologics generally are meeting their regulatory obligations and complete their postmarketing studies in a timely manner, according to a study released today by the U.S. Food and Drug Administration. A review of 1531 open postmarketing studies indicated that over 80 percent are proceeding according to the established timelines, have been submitted for FDA review, or have been determined by the FDA to have met their goals or are no longer needed.

The study, done under a contract with Booz Allen Hamilton and supported by additional funds from Congress, examined the backlog of industry postmarketing studies for FDA-approved drugs and biologics. The review found that most companies meet their obligations in a timely manner.

For more information, visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm181272.htm

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September 4, 2009 - Posted by | 1

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