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February 2018 Office of Women's Health e-Update

Message from the Director

I have good news about women and heart disease. Steps can be taken to prevent this disease by reducing risk factors, managing current health conditions, and making other heart healthy changes. I invite you to partner with us as FDA works to approve treatments, devices and tests to improve the diagnosis and treatment of cardiovascular diseases.
The FDA Office of Women’s Health (OWH) actively supports these efforts by identifying and funding research to provide valuable insight into sex differences related to the diagnosis and treatment of cardiovascular disease. In addition, FDA OWH provides educational tools to help women and their families learn about heart healthy decisions and chronic disease management.
Although heart disease is still the number one killer of women, during American Heart Month, let’s work together to empower women to protect their hearts. It is imperative that we continue to educate researchers and health professionals about the importance of research on heart disease in women. And I encourage you to act today by ordering our heart health kit disclaimer icon, learning tips for a healthy heart, and sharing the heart-related resources in this update.
Marsha Henderson - Associate Commissioner for Women’s Health

Women’s Health Highlights

Cardiovascular Disease Tools for Researchers
OWH has supported research that has led to better understanding of cardiovascular disease in women. Our Research on Heart Disease in Women webpage includes research summaries and an overview of the three phases of OWH-funded research assessing the effects of drugs on women’s heart health.
Resources for Heart Health
OWH has resources with special tips to help women from diverse communities make good decisions about their heart health. Celebrate American Heart Month, by sharing these resources with your networks to help women be heart smart.
New Blog: Pregnancy Exposure Registries Help Moms-To-Be Share Their Experiences with Medicines
OWH’s Director of Scientific Engagement and Medical Initiatives, Dr. Marjorie Jenkins, collaborated with the March of Dimes on a new blog to encourage moms-to-be to participate in pregnancy exposure registries.

Call to Action

Order Free Heart Health Kits
This month, OWH has made available free Heart Health Kits to educate women about their cardiovascular health. Order a kit for you, your loved ones, and the women in your community.
Request for Public Comments: Draft Guidance on Hypertension- Developing Fixed-Dose Combination Drugs for Treatment
FDA is seeking public input and has announced the availability of a Draft Guidance: Hypertension- Developing Fixed-Dose Combination Drugs for Treatment. This draft guidance will help with the development of fixed-dose combination drugs for the treatment of hypertension.
Managing patients who have hypertension often requires that healthcare providers prescribe multiple drugs to control their blood pressure. Fixed-dose drug combinations may help simplify their treatment, increase adherence, and minimize potential side effects. This draft guidance focuses on the development of two-drug combinations of previously approved drugs.


Participate in upcoming Meetings.
Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)
The 21st Century Cures Act established PRGLAC to advise the Secretary of Health and Human Services regarding gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women. PRGLAC is tasked with identifying these gaps and will report its findings back to the Secretary.
February 26, 2018, 8:30 am to 5:00 pm (EST)
February 27, 2018, 8:00 am to 3:00 pm (EST)
National Institutes of Health, Bethesda, MD
Advisory Committee Meeting: Risk Communication
This meeting will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule.
March 5 - 6, 2018, 8:00 am to 5:00 pm (EST)
FDA White Oak Campus, Silver Spring, MD
March 19, 2018, 1:00 pm to 5:00 pm (EST)
FDA White Oak Campus, Silver Spring, MD
Public Meeting: Promoting the Use of Complex Innovative Designs in Clinical Trials
March 20, 2018, 8:30 am to 5:00 pm (EST)
FDA White Oak Campus, Silver Spring, MD
Public Meeting: Evaluating Inclusion and Exclusion Criteria in Clinical Trialsdisclaimer icon
April 16, 2018, 8:30 am to 5:00 pm (EST)
National Press Club, 529 14th St. NW, Washington, DC 20045
Public Meeting on Patient-Focused Drug Development for Opioid Use Disorder
April 17, 2018, 10:00 am to 4:00 pm (EST)
FDA White Oak Campus, Silver Spring, MD
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