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  1. OWH Historical Information

OWH Milestones and Key Events

From the FDA Office of Women's Health

Milestone markers on a road

The FDA Office of Women’s Health was established by Congress in 1994, as part of the Office of the FDA Commissioner. This page highlights some of the significant accomplishments of FDA and OWH to protect and promote women’s health over the years, including key regulations, guidance, and reports related to women’s health. 

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.

This list provides a historical snapshot of FDA actions taken at specific points in time, and may not reflect the latest available guidance or information. 

1990s | 2000s | 2010s 


1993 – Issued “Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs,” which revised the section of the 1977 guideline entitled “General Considerations for the Clinical Evaluation of Drugs” that excluded women of childbearing potential from participation in early studies of drugs. (Current version: Guidance for Industry - Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs)

1994 – Established the Office of Women’s Health (OWH) to protect and advance the health of women through policy, science, and outreach, and to advocate for the participation of women in clinical trials.

1994 – Implemented Mammography Quality Standards Act (MQSA) Program to ensure U.S. mammography facilities meet national standards for equipment, personnel, and quality control.

1994 – Approved the first diagnostic test to detect Her2/Neu gene as an indicator of breast cancer recurrence.

1994 – Approved the first drug treatment for the prevention of HIV transmission from infected pregnant women to their fetuses.

1994-1995 – Issued first consumer safety advisory about the risks to pregnant women and women of childbearing potential caused by consuming certain fish species containing high levels of methyl mercury.

1995 – Approved first of a new class of drugs, bisphosphonates, for the treatment of postmenopausal osteoporosis.

1995 – Established the OWH research program to support regulatory decision-making by providing a greater understanding of the impact of sex differences on medical product safety and efficacy.

1995 – In collaboration with CDER, CBER, and CDRH, OWH convened a workshop, Gender Studies in Product Development: Scientific Issues and Approaches. The meeting was designed to explore the science involved with assessing gender effects during the development of medical products, including drugs, biologics, and medical devices, and to identify significant areas for further research and policy development.

1996 – Approved a liquid-based cytology preparation instrument for use in Pap tests that revolutionizes detection of cervical cancer.

1998 – Launched the Take Time to Care Program to disseminate FDA health and safety information to women and their families, including Pink Ribbon Sunday mammography awareness and Use Medicines Wisely campaigns. Take Time to Care has reached more than 50 million women throughout the U.S. and Puerto Rico.

1998 – OWH-funded research helped FDA identify potentially life-threatening drug-induced cardiac arrhythmias, to which women are especially prone. A popular antihistamine that caused arrhythmia was later withdrawn from the market.

1998 – Approved the first computer software that assists radiologists in detecting mammogram abnormalities.

1998 – Required the addition of folic acid to certain grain products as an essential nutrient to help prevent birth defects of the brain and spine in the developing fetus.

1998 –Issued a final rule, Amendments to Content and Format of a New Drug Application (21 CFR 314.50 (d)(5)). Known as the “Demographic Rule,” it requires NDA sponsors to present safety and effectiveness data by gender, age and racial subgroups and dosage modifications for specific subgroups, and that safety data from other subgroups of the populations of patients treated be present, as appropriate.

1999 – Issued Guidance for Industry: Population Pharmacokinetics, which recommends use of population pharmacokinetics to help identify differences in drug safety and effectiveness among population subgroups. 


2000 – Issued an amendment to the Clinical Hold Regulations for Products Intended for Life-Threatening Diseases (21 CFR 312.42)., which permits FDA to place a clinical hold on IND studies for treatment of a serious or life-threatening disease if women or men are excluded from a clinical trial due to reproductive potential.

2000 – Approved digital mammography systems to detect subtle differences in breast tissue for the screening and diagnosis of breast cancer.

2001 – Approved the first transdermal (skin) patch and first hormonal vaginal ring for birth control.

2002 –Issued Guidance on Establishing Pregnancy Exposure Registries, which explained the need for pregnancy exposure registries, the structure of pregnancy exposure registry studies, and when these studies should be conducted. OWH began providing a list of pregnancy exposure registries publicly in this year.

2002 – In collaboration with key stakeholders, OWH initiated a diabetes awareness campaign to raise public awareness on diabetes prevention and management. 

2003 – Approved first of a new class of drugs to treat moderate to severe Alzheimer’s disease. Two-thirds of patients diagnosed with Alzheimer’s in the U.S. are women. 

2004 – Issued Guidance for Industry on Labeling for Combined Oral Contraceptives that contain estrogen and progesterone.

2004 – Issued Guidance for Industry Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling. Describes a basic framework for designing and conducting PK and PD studies in pregnant women. Recommends how to assess the influence of pregnancy on PK, and where appropriate, the PD of drugs or biologic products.

2004 - 2005 – Created a partnership between OWH, other government agencies and women’s organizations to educate 15 million women about benefits and risks associated with use of hormone therapy for menopause.

2005 – Launched Food Safety for Moms-to-Be outreach initiative to provide information to pregnant women and health educators.

2005 – Issued Guidance for Industry to assess the potential of a drug to affect heart cycle (QT interval prolongation). Women are more likely than men to have certain heart rhythm problems.

2005 – Issued FDA Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies, to help FDA staff evaluate human fetal outcome data generated after medical product exposures during pregnancy.

2006 – Approved the first vaccine for prevention of cervical, vulvar, and vaginal cancers and genital warts caused by certain strains of HPV in females 9-26 years of age.

2009 – Developed a method to analyze lead levels in lipstick.


2010 – Approved a smaller left ventricular assist device for heart failure, acknowledging sex differences in body size.

2011 – Revoked approval of the breast cancer indication for Avastin (bevacisumab) after FDA concluded that the drug had not been shown to be safe and effective for that use.

2011 – Approved the first 3D mammography imaging system (digital breast tomosynthesis) for use with 2D mammography.

2011 – Co-sponsored the Dialogues on Diversifying Clinical Trials conference to promote best practices for the inclusion of women and minorities in clinical research.

2012 – OWH held a meeting with the Centre for Gender Medicine at Karolinska Institutet of Sweden to discuss each institution’s perspective on and approach to addressing women’s health issues.

2013 – Co-sponsored the FDA CDRH Health of Women conference to discuss clinical trial recruitment & retention, analysis and communication, and research roadmap for medical devices.

2013 – Approved first non-hormonal treatment for moderate to severe hot flashes associated with menopause.

2013 - Required manufacturers of zolpidem products to lower the recommended dose for women. Higher drug doses can impair morning activities demanding alertness, such as driving.

2013 - 2014 – Released the FDASIA Section 907 Report and Action Plan on the collection, analysis, and availability of demographic subgroup data for FDA-approved medical products.

2014 – FDA issued guidance on Evaluation of Sex-Specific Data in Medical Device Clinical Studies.

2014 - Issued Guidance for Industry and FDA Staff: Evaluation of Sex-Specific Data in Medical Device Clinical Studies, which outlines FDA’s expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information for medical device applications.

2014 – Approved the first human papillomavirus (HPV) test for primary cervical cancer screening.

2014 – Approved the first medication for treatment of Non-24-Hour Sleep-Wake Disorder, a chronic disruption of the sleep-wake cycle affecting most individuals with total blindness.

2015 – Approved the first treatment for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).

2015 – Approved the first targeted treatment for advanced breast cancer specifically for use in postmenopausal women.

2016 – FDA permitted marketing of the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy.

2016 – FDA allowed marketing of a new tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment of underdeveloped breasts and soft tissue deformities.

2016 – OWH released the Women’s Health Research Roadmap to provide a strategic plan to address seven priority areas where new or enhanced research is important to FDA regulatory decision making on products impacting women’s health.

2016 – OWH, in collaboration with the NIH Office of Research in Women’s Health (ORWH), launched the Diverse Women in Clinical Trial Initiative to raise awareness about the importance of participation of diverse groups of women in clinical research, and to share best practices about clinical research design, recruitment, and subpopulation analyses. 

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