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FDA STUDY INDICATES POSTMARKETING STUDIES MEET TIMELINES.

Publication: Worldwide Databases
Publication Date: 01-OCT-09 		Format: Online
Delivery: Immediate Online Access

Article Excerpt
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...

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