美国FDA 指导原则 妇女和少数群体的指导要求 英文原版.pdfVIP

July 20, 1998 Director, Center for Drug Evaluation and Research FDAMA - Women and Minorities Guidance Requirements Michael A. Friedman, M.D., Acting Commissioner Under the Food and Drug Administration Modernization Act of 1997 (FDAMA) Sec. 115 Clinical Investigations. (b) Women and Minorities. -- Section 505(b)(1) 21 U.S.C. 355(b)(1) was amended by adding at the end the following: “The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as