Women's Health: FDA Guidance Documents

The following guidance documents represent our agency's current views on numerous subjects. Be sure to check back often for updates and new guidelines on emerging topics vital to women's health.

Please note: These guidelines do not confer any rights for or on any individual or organization, nor are they binding documents for the FDA or the public. Alternative approaches may be used if they satisfy the requirements of applicable statutes and regulations.

To obtain additional information on any specific guidance document, please contact the originating office within the appropriate center directly.

Women and Minorities

• Women and Minorities Guidance Requirements
• Investigational New Drug Applications; Clinical Holds
  • Gender Differences in Clinical Evaluation of Drugs
  • Format and Content of Clinical and Statistical Sections of Applications
  • Population Pharmacokinetics (draft guidance)
  • Deadly Diseases and People of Color: Are Clinical Trials an Option?
    • Howard University, Washington, DC, October 25, 1996
    • University of Miami, School of Medicine, Miami, FL, May 5, 1997

Other Clinical/Medical Women's Health-Related Guidances

• Establishing Pregnancy Exposure Registries (9/20/2002)
  (also available as a Word document)
• Evaluation of Human Pregnancy Outcome Data (6/2/1999)
• Establishing Pregnancy Registries (6/2/1999)
• Clinical Evaluation of Combination Estrogen/Progestin Containing drug products used for HRT in post-menopausal women
  • Vaginal Contraceptive Guidance
  • Preclinical and Clinical Treatment used in prevention of postmenopausal osteoporosis

Additional information on these and other guidances may be found under "Women's Health Initiatives" on FDA's Center for Drug Evaluation and Research Website.

Policies

Federal Register notice (Feb. 11, 1998) to amend regulations for NDAs to clearly define in NDA format and content regulations the requirement to present effectiveness and safety data for important demographic subgroups, specifically gender, age, and racial subgroups.

Some of these documents are PDF files or Microsoft Word files. The PDF files can be viewed with the Adobe Acrobat Reader, which is free from their Website. Microsoft Word files can be viewed with that application or with a document viewer available free from the Microsoft Website. If you need additional information about viewing these types of files, please consult General Help for Accessing Files.