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On January 23, 2003 the FDA released a guidance document which provided a guideline FOR COLLECTION OF RACE AND ETHNICITY DATA IN CLINICAL TRIALS FOR FDA REGULATED PRODUCTS.

Though this document addresses the FDA main concern with INDs for NDAs the FDA goes on to state that if a Sponsor of an IDE for a medical device and if they become aware of any race related problems that this guideline should also be used in those cases.

For more information on this Guidance Document please visit the following site:

http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01193.html

View draft guidance at http://www.fda.gov/cder/guidance/5054dft.doc or http://www.fda.gov/cder/guidance/5054dft.pdf.

U.S. AGENT SECTION

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