Extramural Research – Women’s Health
From the FDA Office of Women's Health
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On this page: Areas of interest | BAA funding | CERSIs | Related links
OWH-funded extramural research
OWH supports scientific research to advance the science of women’s health in the form of grants, cooperative agreements, or contracts.
Areas of interest
The Women’s Health Research Roadmap provides a framework for continuing to integrate women’s health science into all of FDA’s research activities, including information about priority areas for OWH-funded research.
BAA funding
Extramural research at FDA is primarily funded through a Broad Agency Announcement (BAA). The FDA BAA is open to all responsible sources, and small businesses are strongly encouraged to respond. Offerors may include single entities or teams from private sector organizations, Federally Funded Research and Development Centers (FFRDCs), and/or academic institutions.
More information about FDA’s Office of Women’s Health areas of interest can be found in the FY24 BAA PDF (832.39 KB), including:
Charge I: Modernize development and evaluation of FDA-regulated products
- Develop alternative methods in support of development of diagnostics and therapeutics targeting women, including, but not limited to:
- Methods to evaluate innovative, new devices and diagnostics specifically designed for use in women.
- Methods to enhance the evaluation of devices used in both men and women to take into consideration sex differences like organ size/anatomy/ physiology/human factors differences that may affect device performance.
- Foster development methods to evaluate sex-matched devices and companion diagnostics. Develop methods to evaluate FDA regulated-product safety and effectiveness during pregnancy and lactation
- Develop methods to evaluate FDA regulated-product safety and effectiveness during pregnancy and lactation
- Develop methods to evaluate sex differences in the safety and efficacy of FDA regulated products
- Develop novel tools to evaluate regulated-product toxicity or the safety and efficacy during pregnancy and lactation
- Identify, develop, evaluate, and qualify biomarkers that can better measure and predict the safety and efficacy of FDA- regulated products in women in non- or preclinical studies and during clinical trials
- Identify, develop, and evaluate biomarkers for the identification of sex differences in the performance of medical products
- Assess the impact of lifestyle factors, including but not limited to, diet, exercise, and stress on health conditions that uniquely or disproportionately impact women
- Develop and validate new patient-reported outcome measures that capture the unique experiences and challenges faced by women in relation to their health
- Improve clinical study design and conduct to examine diseases and conditions primarily affecting women across the lifespan, including during pregnancy, lactation, and pre- and post- menopause.
- Develop analytical methods for interpreting and using data on sex differences from trials and studies with small sample sizes.
- Identify and evaluate best practices for the recruitment and retention of women in clinical trials (e.g., new strategies, approaches).
- Identify appropriate endpoints and outcome measures, including patient reported outcome measures, for diseases or medical products that may affect women differently from men (e.g., certain types of cardiovascular disease present differently in men than in women).
- Investigate the differences in pharmacokinetics and pharmacodynamics between sexes to determine how drug absorption, distribution, metabolism, and elimination may impact toxicity predictions and optimal dosing
- Identify specific biomarkers and genetic factors that contribute to sex-based variations in drug metabolism and response, and evaluate their role in predicting potential toxic effects.
- Investigate the impact of hormonal fluctuations, such as those occurring during the menstrual cycle and menopause, on drug metabolism and toxicity, and integrate this knowledge into predictive models.
- Evaluate methodologies for the identification of clinically relevant sex differences, using a variety of RWD sources
- Conduct studies using RWD to evaluate the toxicity or the safety, effectiveness, and health effects of FDA-regulated products used by women, including the examination of sex differences
- Develop efficient data mining and analysis techniques that can be used on RWD sets that can specifically identify women’s health issues on a larger scale.
Charge II: Strengthen post-market surveillance and labeling of regulated products
- Evaluate and validate U.S. and international RWD sources for use in the identification of the potential adverse effects and sex differences on the safety and effectiveness of FDA-regulated products used by women (page 41)
- Evaluate methodologies for the identification of clinically relevant sex and gender differences, using a variety of RWD sources (page 41)
- Conduct studies, using RWD sources to evaluate the safety and effectiveness, of FDA-regulated products used by women, including the examination of sex and gender differences (page 42)
- Develop and evaluate data sources and efficient techniques for data mining, linkage, and large-scale analysis that can be used to assess real-world evidence, including post-market safety and utilization of FDA-regulated products to specifically identify sex and gender differences or women’s health issues.
- Identify, develop, and evaluate data sources and efficient techniques for data mining, data linkage, and large data set analysis that can be used to assess the safety and effectiveness of FDA-regulated products, to specifically identify women’s health issues.
- Identify how factors such as sex, gender, age, literacy level, and native language can affect a woman’s understanding of FDA product information and its influence on her subsequent health-related decisions
- Evaluate the reach and impact of FDA communications about FDA-regulated products used by women, including but not limited to identifying and evaluating methods for communicating:
- FDA information to special populations of women, including elderly women, women with disabilities, caregivers, pregnant and lactating women, and women with limited English proficiency
- Specific information about sex and gender differences
- Risks of certain medical product exposures, food consumption (e.g., seafood), and the use of tobacco products during pregnancy and lactation
- Information about drug exposure during breast-feeding
- Explore methods for using social media to identify gaps in knowledge, misinformation, or sentiments about specific women’s health issues and related FDA regulated products.
Charge III: Invigorate public health preparedness and response of the FDA, patients, and consumers
- Develop tools to identify public health threats, prevent them from becoming crises, and promote public health security, with a focus on women
- Assess whether medical countermeasures—such as drugs, vaccines, and diagnostic tests—include women during development and include an evaluation of sex differences
- Assess the prevalence and patterns of substance use (including tobacco, alcohol, prescription medications, and illicit drugs) among pregnant women, and investigate its association with maternal mortality
Additional information about this solicitation is available at:
- Regulatory Science Extramural Research and Development Projects, including BAA funding deadlines and information about previously funded FDA projects
- SAM.gov - Funding notice ID FDABAA-24-00123
- FDA BAA FY 2024 (PDF, 832 KB)
- FDA BAA Questions & Answers
- 2023 FDA Broad Agency Announcement Day (October 25, 2023, virtual) – View the recording and event materials to learn more about the FY 2024 BAA, and how to apply.
- 2022 FDA Broad Agency Announcement Day, including a presentation from OWH (PDF, 612 KB)
CERSIs
FDA Centers of Excellence in Regulatory Science and Innovation (CERSIs) are collaborations between FDA and academic institutions to advance regulatory science through innovative research, training, and scientific exchanges. OWH works with various CERSIs to fund research projects.
Current OWH-funded CERSI projects
Learn more
If you have questions about OWH extramural research, please contact FDA Office of Women's Health at fda-owh@fda.hhs.gov.
Related links
- CERSI Research Projects – information about additional CERSI projects FDA-wide
- CERSI Workshops and Training
- CERSI Lecture Series and Webinars
- CERSI Publications