Science & Research

Regulations, Guidance, and Reports related to Women’s Health

FDA has been committed to addressing women’s health since its inception in 1906, as illustrated by events in its history, such as FDA’s reversal of guidance that effectively excluded women of childbearing potential (WOCBP) from clinical studies. Guidance and other FDA regulations are ways in which FDA communicates its current thinking on issues related to FDA regulated products (evaluation, development, etc.). Several of these regulatory documents have addressed women’s health over FDA’s history and have impacted the way in which women are enrolled in clinical trials and sex analyses are conducted. 

1960s

  • 1960s Evidence of fetal malformation from thalidomide use in Europe prevented its approval in the United States. It also prompted fears of including women of childbearing potential in clinical trials. [FDA Backgrounder]

1970s

1980s

1990s

  • 1992 GAO report Women’s Health: FDA Needs to Ensure More Study of Gender Differences in Prescription Drugs Testing. The results of this report (from NMEs approved Jan 1988-June 1991) concluded that women were not adequately included in clinical trials based on the proportion of women with the diseases for which the studied drugs were intended. Also, trial data was often not analyzed for sex differences in therapeutic response. Report
  • 1993 FDA Guidance Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs. Withdrew the restriction (as outlined in the 1977 guidance) on the participation of women of childbearing potential in early clinical trials including clinical pharmacology studies and early therapeutic studies. Recommends pharmacokinetics and pharmacodynamics in women, pharmacokinetic screen as a tool to detect difference, analysis of safety and efficacy by sex. Guidance
  • 1997 FDAMA Section 115: Clinical Investigations (b) Women and Minorities Regulation. Requires FDA and NIH along with representatives of the drug manufacturing industry to review and develop guidance on inclusion of women and minorities in clinical trials. Regulation
  • 1998 Demographic Rule – Amendments to Content and Format of a New Drug Application (21 CFR 314.50 (d)(5). This final rule, known as the “Demographic Rule” revised the NDA content and format regulations at 21 CFR 314.50 to require effectiveness data to be presented by gender, age and racial subgroups and dosage modifications be identified for specific subgroups. Also requires safety data be presented by gender, age and racial subgroups; and that safety data from other subgroups of the populations of patients treated be presented, as appropriate. Regulation
  • 1998 Investigational New Drug (IND) Applications - Annual Reports (21 CFR 312.33). Requires investigational new drug (IND) data regarding participation in clinical trials be presented in annual reports by sex, age, and race. Regulation
  • 1999 FDA Guidance for Industry Population Pharmacokinetics. Recommends use of population pharmacokinetics to help identify differences in drug safety and effectiveness among population subgroups. Guidance

2000s

2010s

Page Last Updated: 08/20/2018
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