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Message from the Associate Commissioner
Dear Women’s Health Colleagues,
This October, I am pleased to share some exciting updates and highlight key observances that are especially meaningful to our commitment to women’s health. First, I am thrilled to announce the release of OWH’s updated Women’s Health Research Roadmap, which outlines our research priorities and reinforces OWH’s dedication to advancing the science that improves the health of women. The roadmap provides a framework to address women’s health research questions that will inform regulatory science by identifying priority areas where new or additional research is needed. It serves as a guide for researchers, and other interested parties as we continue to work to address the unique health needs of women through science and innovation. I invite you to visit our website to learn more about our Women’s Health Research Roadmap.
October is also breast cancer awareness month. Each year, approximately 270,000 women get diagnosed with breast cancer in the United States and 42,000 die from the disease.1 It is the second most common cancer among women in the United States. Breast Cancer Awareness Month serves as an important reminder of the importance of screening and early detection. Mammograms can help save lives and continues to be the best primary tool to screen for breast cancer. Last month, the final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act) went into effect. FDA Facilities subject to the MQSA and its implementing regulations must now comply with all the requirements, including the breast density notification. Learn more in the "Call to Action" section below.
I am also pleased to introduce Folajomi “Jomi” Kiladejo as OWH’s new Director of Outreach and Communications. With a wealth of experience in public health communications and a passion for advancing women’s health, Jomi will be pivotal in amplifying our outreach efforts and ensuring that we effectively reach and impact the communities we serve. Please join me in welcoming and congratulating Jomi on her new role.
We look forward to continuing our work to protect and promote the health of women through science, education, and collaboration.
Sincerely,
Kaveeta P. Vasisht, M.D., Pharm.D.
Associate Commissioner for Women’s Health
Director, Office of Women’s Health (OWH)
1 https://www.cdc.gov/cancer/features/breast-cancer.html
 Introducing OWH’s Director for Outreach and Communications
We are pleased to introduce Folajomi “Jomi” Kiladejo as the new Director of Outreach and Communications at the FDA Office of Women’s Health. Prior to joining OWH, Jomi worked as a campaign manager at FDA Center for Tobacco Products (CTP), serving across various tobacco public education campaigns. Her work focused on driving behavior change through digital mediums and the challenge of translating complex science to understandable and relatable messages that help target audiences make informed decisions about their health and well-being.
Jomi has recently served as the Acting Director for Outreach and Communications here at OWH where she worked to advance the mission of the Office through the implementation of initiatives that inform, educate, and engage women’s health interested parties about critical health topics and FDA regulated products. In the permanent role, Jomi oversees a team of public health professionals and will work to advance the mission of the office.
  Menopause Awareness Month
Hot flashes? Irregular periods? Mood changes? Menopause is a normal, natural change in a woman’s life when her period stops. Menopause affects women differently. Every woman’s period will stop at menopause. Some women may have other symptoms of menopause, while some may not have any other symptoms at all. Check out our menopause tips and resources to help you talk with your health care provider about managing your symptoms before, during, and after menopause. These resources include a consumer-focused Menopause & Hormones - Common Questions fact sheet on hormone therapy for menopause.
In case you missed it, last month FDA released a Drug Safety Communication warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. Veozah is a nonhormonal prescription medicine approved to reduce the frequency and severity of moderate to severe hot flashes caused by menopause. Patients should stop taking Veozah immediately and seek medical attention if they experience signs and symptoms that suggest liver problems such as feeling more tired than usual; nausea; vomiting; unusual itching; light-colored stools; yellowing of the eyes or skin, called jaundice; dark urine; swelling in the abdomen; or pain in the right upper abdomen. Stopping the medicine could prevent worsening liver injury and potentially return liver function to normal.
  Breast Cancer Awareness Month
Mammograms can help detect breast cancer when it is in its early, most treatable stages. October is Breast Cancer Awareness Month—a great reminder to talk with your health care provider about scheduling your mammogram. We encourage you to explore our mammography resources (en Español) and share them with your communities. Additional mammography resources from OWH include:
It is also a great time to raise awareness of FDA’s role in regulating mammography facilities. Since 1992, the FDA Mammography Quality Standards Act and Program has worked to ensure quality mammography throughout the U.S. On September 10, 2024, the FDA updated Important Information: Final Rule to Amend the Mammography Quality Standards Act (MQSA). Facilities are now subject to all applicable MQSA requirements, including those in the 2023 MQSA Final Rule.
 Women’s health news and updates
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Mammography Quality Standards Act (MQSA) and MQSA Program
- The FDA Center for Devices and Radiological Health (CDRH) is highlighting that the new requirements of the 2023 Mammography Quality Standards Act (MQSA) final rule that amended federal standards to incorporate current science and mammography best practices are now in effect.
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The Facts on Tampons—and How to Use Them Safely
- Tampons are one method of absorbing menstrual flow during your period. If you use tampons during your period (or menstruation), it’s important to know how to use them safely. The FDA is aware of concerns about tampon safety after a 2024 study found metals in tampons during laboratory testing. More information can be found here.
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Should Your Child Participate in a Clinical Trial?
- Clinical trials help provide reliable evidence needed when studying medical products to diagnose, prevent, treat, and sometimes even cure, childhood diseases. Children who participate in these research studies may also potentially benefit from the medical products under investigation. Before deciding whether your child should participate in a clinical trial, there’s a lot to know, including the risks and benefits.
More updates from around FDA
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.
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