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Women's Health : FDA Needs to Ensure More Study of Gender Differences in Prescription Drugs Testing: Hrd-93-17. U S Government Accountability Office (G

Author: U S Government Accountability Office (G
Date: 26 Jun 2013
Publisher: Bibliogov
Original Languages: English
Format: Paperback::48 pages
ISBN10: 1289029326
ISBN13: 9781289029326
Publication City/Country: United States
File size: 18 Mb
Filename: women's-health-fda-needs-to-ensure-more-study-of-gender-differences-in-prescription-drugs-testing-hrd-93-17.pdf
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Ethics, Epidemiology, and Women's Health Carol Levine, MA INTRODUCTION In a sharp departure from the past, women's health is moving from the sidelines to the playing field. While most current discussions of the need to expand research on women's health have focused on clinical drug trials, epidemiologic studies will make an important ensure the highest quality of reproduction possible. If pages are missing, contact the university which granted the degree. Sorne pages may have indistinct print especially if the original pages were typed with a poor typewriter ribbon or if the university sent us an inferior photocopy. Reproduction in full or in part of this microform is “Women’s Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing.” GAO/HRD-93-17. Washington, D.C.: GAO. Id. NIH Revitalization Act of 1993 (Public Law 103-43). Reintroduced in 1991, the Women’s Health Equity Act (WHEA) contained 22 bills that addressed research, care, and prevention issues in women’s (But see GAO, "Women's Health: FDA Needs to Ensure More Study of Gender Difference in Prescription Drug Testing," GAO/HRD-93-17, October 1992; SAWHR, 1991). Instead, it is written on the assumption that further research would reveal that many, but not all, drugs and therapeutic interventions have different degrees of risk and efficacy in male Women’s Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing. GAO/HRD-93-17. He was a charter member of the Society for Women’s Health Research Interdisciplinary Studies in Sex-differences Network on Sex, Gender, Drugs and the Brain. Free Online Library: Women's health: librarian as social entrepreneur. "Library Trends"; Library and information science Drug wholesalers Genetic aspects Political aspects Entrepreneurship Health care information services Medical advice systems Medical research Medicine, Experimental Publishing industry Political activity Sales management Women's Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing. Washington, D.C.: U.S. Government Printing Office, October 1992. GAO/HRD-93-17. Van Lier, Donna J., and Roberts, Joyce E. "Promoting Informed Consent of Women in Labor. Women's health: FDA needs to ensure more study of gender differences in prescription drug testing. Washington, DC: Government Printing Office; Report No. GAO/HRD 93-17,1992. The Willowbrook war. This review outlines the history and progress of women’s inclusion in clinical trials for prescription drugs and presents considerations for researchers, clinicians, and academicians on this issue. FDA needs to ensure more study of gender differences in prescription drug testing. Why women’s health can’t wait A report of the Mary Sincethe early 1990s, the FDA Office of Women’s Health and the Society for Women’s HealthResearch (SWHR) have worked toward the common goals of advancing women’s health research through On July 22, 1993, the FDA issued a new guideline titled Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs. 58 Fed. Reg. 39406–39416.The new guideline revises the section titled "Women of Childbearing Potential" in the FDA's 1977 guidelines, General Considerations for the Clinical Evaluation of Drugs, and describes the agency's expectations 5See U.S. GENERAL ACCOUNTING OFFICE, GAO/HRD-93-17, WOMEN'S HEALTH: FDA NEEDS TO ENSURE MORE STUDY OF GENDER DIFFERENCES IN PRESCRIPTION DRUG TESTING (October 1992). This GAO survey of drug manufacturers that obtained FDA approval of new drugs from January 1988 through June 1991 concluded that gender-related differences in response do exist Women’s involvement in clinical trials: Historical perspective and future implications clinical trials for prescription drugs and presents.1994 Office of Women’s Health Established In the same year, following the US General Accounting Office’s report on the FDA’s policy toward women titled, “Women’s Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drug Testing,” the FDA issued their “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs Nearly a decade before women's exclusion from clinical research became an issue of public scrutiny and political debate, a 1981 article documented women's underrepresentation in drug trials. The article observed that conservative Food and Drug Administration (FDA) policies which discouraged the inclusion of women of ''childbearing potential'' in early drug trials led to their widespread

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