FDA, EMEA Launch Clinical Trial Oversight Program

Law360, New York (August 3, 2009, 3:48 PM EDT) -- The U.S. Food and Drug Administration and the European Medicines Agency have launched a joint initiative to ensure the use of safe and effective practices in clinical trials as part of the drug approval process.

The FDA announced Monday that the two agencies had launched the Good Clinical Practices initiative, a program meant to make sure that clinical trials submitted in support of drug approval applications in the U.S. and Europe are conducted “uniformly, appropriately and ethically.”

The program will begin Sept. 1 with an 18-month...
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