References

Lesson 2

Legislative Process Framework : References

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1. U.S. Department of Health and Human Services, Food and Drug Administration. Guidance documents. Retrieved February 3, 2006, from FDA Center for Drug Evaluation and Research Web site: http://www.fda.gov/cder/guidance/index.htm.
2. U.S. Department of Health and Human Services. Office for Human Research Protections home page. Retrieved February 3, 2006 from: http://www.hhs.gov/ohrp/.
3. U.S. Department of Health and Human Services. Protection of Human Subjects: General requirements for informed consent, 45 C.F.R. Part 46.116 (2005). Retrieved February 3, 2006, from HHS Office for Human Research Protections Web site: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116.
4. U.S. Department of Health and Human Services. Memorandum on compliance oversight procedures. Retrieved February 3, 2006, from HHS Office for Human Research Protections Web site: http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf.
5. U.S. Department of Health and Human Services, Food and Drug Administration. (1993). Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs, 58 Fed. Reg. 39406 (1993). Retrieved February 3, 2006, from FDA Center for Drug Evaluation and Research Web site: http://www.fda.gov/cder/guidance/old036fn.pdf.
6. U.S. Department of Health and Human Services, Food and Drug Administration. (1995). Historical overview: Women of childbearing potential and early clinical trials. Executive Summary--Gender studies in product development. (1995) Retrieved February 3, 2006, from U.S. Food and Drug Administration Web site: www.fda.gov/womens/gender/Exec4.htm.
7. Mathieu, M. (1997). New drug development a regulatory overview. Waltham, MA: PAREXEL International, p.20.
8. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. (1997). Gender considerations in the conduct of clinical trials. Retrieved February 3, 2006 from http://www.ich.org/LOB/media/MEDIA1728.pdf.
9. U.S. Department of Health and Human Services, Food and Drug Administration. (1998). FDAMA women and minorities working group report. Retrieved February 3, 2006, from FDA Center for Drug Evaluation and Research Web site: http://www.fda.gov/cder/guidance/women.pdf.
10. U.S. Department of Health and Human Services, Food and Drug Administration. (2003). Guidance for industry: Collection of race and ethnicity data in clinical trials. Retrieved February 3, 2006, from FDA Center for Drug Evaluation and Research Web site: http://www.fda.gov/cber/gdlns/racethclin.pdf.
11. U.S. Department of Health and Human Services. National Institutes of Health. (2001). NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research - Amended October, 2001. Retrieved February 3, 2006, from NIH Office of Extramural Research Web site: http://grants2.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
12. U.S. Department of Health and Human Services. National Institutes of Health. NIH Revitalization Act of 1993, Subtitle B: Clinical research equity regarding women and minorities. (1993). Retrieved February 3, 2006, from Office of Research on Women's Health Web site: http://orwh.od.nih.gov/inclusion/revitalization.pdf.
13. U.S. Department of Health and Human Services. National Institutes of Health. (1994). NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Retrieved February 3, 2006, from National Institutes of Health Web site: http://grants.nih.gov/grants/guide/notice-files/not94-100.html.
14. U.S. Department of Health and Human Services. National Institutes of Health. (2000). NIH guidelines on the inclusion of women and minorities as subjects in clinical research - Updated August 2, 2000. Retrieved February 3, 2006, from National Institutes of Health Web site: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html.
15. U.S. Department of Health and Human Services. National Institutes of Health. (2001). NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research - Amended October, 2001.
16. U.S. Department of Health and Human Services, National Institutes of Health. (2002). Outreach notebook for the inclusion, recruitment, and retention of women and minority subjects in clinical research. Retrieved February 3, 2006, from Office of Research on Women's Health Web site: http://orwh.od.nih.gov/pubs/outreach.pdf.
17. U.S. Department of Health and Human Services, National Institutes of Health. (2003). Science meets reality: Recruitment and retention of women in clinical studies and the critical role of relevance, a report of the Task Force sponsored by the NIH Office of Research on Women's Health, January 6-9, 2003. Retrieved February 3, 2006, from Office of Research on Women's Health Web site: http://orwh.od.nih.gov/pubs/SMR_Final.pdf.