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  6. Cross-cutting Topics: Women’s Health Regulatory Science Research
  1. Focus Areas of Regulatory Science Report

Cross-cutting Topics: Women’s Health Regulatory Science Research

 

Doctor using stethoscope on senior female patient.

Women’s Health Research is a critical element in regulatory science because medical products can affect men and women differently. FDA’s Office of Women’s Health (OWH) sets the Agency’s research agenda for women and funds research and development activities related to advancing the science of women’s health and sex and gender differences. OWH collaborates across FDA to identify priority topic areas to create OWH’s Women’s Health Research Roadmap. The Office focuses funding on cross-cutting research within FDA centers to expand existing research projects and foster new collaborations. In addition, OWH works with other governmental agencies, academia, women’s research organizations, and other stakeholders to facilitate research projects and scientific forums to advance FDA’s understanding of women’s health and the impact of sex and gender differences on health, disease, and medicine. OWH’s work advances regulatory science through the development of new tools and approaches to inform FDA decisions about the safety, effectiveness, or reduction of associated harms of FDA-regulated products that are used not only by women, but by all Americans.

OWH awards intramural research grants and extramural funding through the Advancing Regulatory Science Broad Agency Announcement and Centers of Excellence in Regulatory Science and Innovation programs. The programs support regulatory science research that addresses knowledge gaps in sex and gender differences in product safety and effectiveness, and women’s health concerns related to FDA-regulated therapeutic products. OWH funds research that concerns health issues affecting women across their lifespan, including cardiovascular disease, breast cancer, medical device and nutritional supplement safety, pregnancy and lactation, and reproductive health. In addition, OWH works across government agencies and with external stakeholders to advocate for research inclusion and real-world data collection to inform and improve the safety of FDA-regulated products used during pregnancy and lactation. Results from OWH-supported research have led to safety-related labeling changes, product development guidance for industry, and new evidence-based communications about FDA-regulated products used by pregnant and lactating individuals. Learn more about women’s health regulatory science research.

OWH Mission
The FDA Office of Women’s Health (OWH) serves as the principal advisor to the Commissioner and other key Agency officials on scientific, ethical, and policy issues relating to women’s health. OWH coordinates efforts to establish and advance a women’s health agenda for the Agency, promotes the inclusion of women in clinical trials and the implementation of guidelines concerning the representation of women in clinical trials and the completion of sex/gender analysis. OWH also identifies and monitors emerging women’s health needs, and serves as the Agency’s liaison with other agencies, industry, professional associations and advocacy groups with regards to the health of women. OWH achieves its mission through the foundational principle that sex as a biological variable should be factored into research design, analysis, reporting and education. To this end, OWH supports FDA’s regulatory mission by engaging in scientific research and collaborating with stakeholders to engage in scientific and educational projects. These initiatives are coordinated through research and development, education, and public outreach.

 

 

CROSS-CUTTING TOPICS

Minority Health and Health Equity Women’s Health Maternal Health Pediatric Health
Oncology Rare Diseases One Health Initiative  

 

EXPLORE THE FOCUS AREAS OF REGULATORY SCIENCE

Advanced Manufacturing Antimicrobial Resistance Artificial Intelligence Biomarkers
Complex Innovative Trial Design Digital Health Technologies Empowering Patients and Consumers to Make Better-Informed Decisions Food Safety
Increasing Access to Complex Generic Drug Products Individualized Therapeutics and Precision Medicine Medical Countermeasures and Preparedness for Emerging Infectious Diseases Microbiome Research
Model-Informed Product Development Novel Foods and Food Ingredients Novel Technologies to Improve Predictivity of Non-clinical Studies and Replace, Reduce, and Refine Reliance on Animal Testing Patient and Consumer Preferences and Perspectives
Patient-Reported Outcomes and other Clinical Outcome Assessments Product Safety Surveillance Quality of Compounded Drugs Regenerative Medicine
  Substance Use Disorders Technologies to Reduce Pathogen Contamination Use of Real-World Evidence to Support Biologic, Device, and Drug Development and Regulatory Decision-Making

 

Research Capabilities, Tools, and Resources

Research Management and Collaborations Technology Transfer and Public-Private Partnerships Physical Standards and Reference Materials Intramural Grant Programs Extramural Funding Mechanisms

Scientific Education, Training, and Communication

Fellowship and Training Opportunities Professional Development and Continuing Education Communication and External Meetings

Infrastructure

Facilities and Shared Resources Safety and Compliance

 

ADDITIONAL ORGANIZATIONAL INFORMATION

Office of the Chief Scientist

Office of Regulatory Science and Innovation

 Contact Us: FARS@fda.hhs.gov

 

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