FDA’s Office of Women’s Health

by | Mar 10, 2021 | FDA, Quality, Women Owned, Women's Health

In today’s day and age, women’s health is more important than ever. There are several international health initiatives directed at providing resources and improving the overall health of women globally. In alignment with that, the FDA also has its own established Office of Women’s Health (OWH). The OWH was established in 1994 with the main mission to serve as the principal adviser to the FDA Commissioner on “scientific, ethical, and policy issues related to women’s health”.1

A key part of the OWH’s mission is accomplished by funding research grants for 1-2 studies each year that address women’s health issues and the impact of gender differences on the safety and efficacy of drugs and medical devices. These studies also typically address certain regulatory questions when it comes to the effects of gender on FDA-regulated products. In 2020, one of the studies that the OWH funded was on the sex differences in Alzheimer’s disease. This study investigated novel technologies for the discovery of potential biomarkers and new therapies for women with the disease. Additionally, the OWH also funded a study in 2020 that looked at the sex differences in the expression of biomarkers that could diagnose early HIV-1 infections.2

On top of the groundbreaking research that the OWH funds annually, the office also works towards increasing the number of diverse women in clinical trials. It is important to include women of different ages, ethnic backgrounds, and disabilities in clinical trials to ensure the safety and efficacy of the product are consistent across all populations. The OWH’s Diverse Women in Clinical Trials Initiative also helps the industry share best practices about clinical trial design, recruitment, and subpopulation analyses.3

The OWH has also founded numerous community outreach programs such as the Mammography Awareness Initiative, Use Medicines Wisely Campaign, and the Take Time to Care Program which provides reliable health information targeted at Women’s Health. I have been honored to work with several firms that have women’s health products during my time with EMMA International. Whether it is during the clinical trial phase of these products or assisting with the regulatory submissions to get these products on the market, it is a great feeling knowing that I am playing a small part in the global initiative towards equality in the healthcare space for women. If you need help with any quality, regulatory, or compliance aspect of your product, EMMA International’s team of experts has you covered! Contact us at 248-987-4497 or email info@emmainternational.com today!


1FDA (December 2019) Office of Women’s Health retrieved on 03/07/2021 from: https://www.fda.gov/about-fda/office-commissioner/office-womens-health

2FDA (July 2020) List of OWH Research Program Awards by Funding Year retrieved on 03/07/2021 from: https://www.fda.gov/science-research/womens-health-research/list-owh-research-program-awards-funding-year

3FDA (August 2019) Women in Clinical Trials retrieved on 03/07/2021 from: https://www.fda.gov/consumers/womens-health-topics/women-clinical-trials

Madison Wheeler

Madison Wheeler

Director of Technical Operations - Ms. Wheeler serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Ms. Wheeler also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Ms. Wheeler holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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