Read about Heart Health, Opioids and more in the February eUpdate

February 2016
www.fda.gov/womens

Message from the Director

During American Heart Month, I want to remind you that women’s heart health is a priority for FDA. The Agency works to review and approve tests, devices and medicines to improve the diagnosis and treatment of cardiovascular diseases. The Office of Women’s Health actively facilitates these efforts by identifying and funding research to better understand cardiovascular diseases in women. We also provide outreach tools to diverse communities of women to increase awareness about heart healthy lifestyle choices and chronic disease management.  Visit our newly updated Research on Heart Disease in Women webpage and our Heart Health for Womenresource portal to learn how FDA is making a difference. I also encourage you to check the announcements in this update to learn about  upcoming meetings and other activities related to heart disease. 

Lastly, I am happy to announce OWH’s new leadership team: Dr. Pamela Scott - Deputy Director, Dr. Marjorie Jenkins – Director of Medical Initiatives and Scientific Engagement and Kimberly Thomas - Director of Outreach and Communications.

Marsha Henderson, Assistant Commissioner for Women’s Health

4 Tips for Better Heart Health for Women

FDA’s Heart Health for Women webpage highlights four tipsand other resources on nutrition, aspirin, and safe medication use that can help women make good decisions about their heart health. Throughout the month of February, share these tips with your networks to help women be heartsmart. Visit the Women and Heart Health webpage

New FDA Opioid Action Plan

While opioids can help women deal with chronic or severe pain, misuse and abuse of these drugs can be fatal. FDA has developed a comprehensive action plan to take concrete steps toward reducing the impact of opioid abuse on American families and communities. The action plan includes steps that will enhance safety labeling; require new data; and seek to improve treatment of both addiction and pain. Read the FDA Opioid Action Plan

FDA Perspectives on Diversifying Clinical Trials

Increasing diversity in clinical trials is a priority of FDA. FDA’s Centers and Offices are conducting a range of activities to enhance clinical trial design, recruitment, and data availability. Read two recent blogs by FDA leaders to learn more about these ongoing efforts.

Read the “Participate in a Clinical Trial: Make a Difference” blog post by Marsha Henderson

Read the “2016: The Year of Diversity in Clinical Trials” blog post by Dr. Robert Califf

---

Feb. 29 Public Meeting on FDASIA Section 907

FDA will conduct a public meeting to present the Agency's progress in implementing the “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,” required under Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA). The last day to register for this meeting is February 13.

Register for the Meeting

Submit Electronic Comments

FDA Meetings

Risk Communication Advisory Committee Meeting

February 16-17, 9:00 am to 5 pm, FDA White Oak Campus

Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting

February 18, 8:00 am to 6:00pm, Hilton Washington DC North/Gaithersburg

Food and Drug Administration Patient and Medical Professional Perspectives on the Return of Genetic Test Results

March 2, 2016, 8:00 am to 4:00 pm, FDA White Oak Campus

Patient Focused Drug Development Meeting: Psoriasis

March 17, 2016, 10:00 am to 6:00 pm, Location TBD