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Women in clinical studies

Executive Summary

General Accounting Office follow-up report on FDA practices for inclusion of women in clinical drug trials requested by Sens. Harkin (D-Iowa), Mikulski (D-Md.) and Snowe (R-Maine) and Rep. Waxman (D-Calif.) in a May 2 letter. The report will assess changes that have occurred since a 1992 GAO report found inadequate representation of women in clinical trials. FDA issued a proposed rule in 1997 that would require inclusion of women of child-bearing potential in trials

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