AEGiS-GMHC: TREATMENT BRIEFS: Women in Clinical Studies

Important note: Information in this article was accurate in 1993. The state of the art may have changed since the publication date.

TREATMENT BRIEFS: Women in Clinical Studies

Gay Men's Health Crisis: Treatment Issues, Volume 7 no. 9 - October, 1993
David Gold

The FDA published new guidelines for the enrollment of women into clinical trials. The new guidelines, published in the Federal Register July 22, would replace earlier guidelines developed in the 1970's that excluded women from clinical trials. Garance Franke-Ruta, a New York-based AIDS activist, said that the new guidelines "were a step in the right direction, but didn't go far enough." She added that the FDA needs to develop guidelines specifically for women with life- threatening diseases. Written public comments on the new regulations are due by November 19 to: Dockets Management Branch, HFA-305, Food and Drug Administration, Room 1-23, 12420 Parklawn Dr. Rockville, MD 20857. In written comments, note "Docket Number 93D-0236." For more information, contact Patrick Savino at the FDA 301/295-8012.

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