Message from the Director

October is the time when we get to highlight two women’s health issues central to our work at FDA: safe medication use and mammography. This month is ‘Talk about Your Medicines’ Month. I hope that you will continue to look to FDA for educational resources and product safety information that consumers and health professionals can use to make informed decisions about the use of prescription and over-the-counter medicines.

In October, we also observe Breast Cancer Awareness Month. Since 1992, FDA’s Mammography Quality Standards Act Program has worked to ensure quality mammography throughout the U.S. OWH has supported these efforts through our Pink Ribbon Sunday Mammography Awareness Programdesigned to educate women about the breast cancer early detection. FDA also supports research to better understand the safety and efficacy of medicines and devices used in breast cancer screening and treatment. I encourage you to read this update to learn more about these activities and our other initiatives, meetings and resources.

Marsha Henderson, Assistant Commissioner for Women’s Health

FDA WOMEN'S HEALTH HIGHLIGHTS

Clinical Trials Webinar Series

The Association of Clinical Research Professionals, in conjunction with the FDA Office of Women’s Health, will be hosting a new webinar series on Diverse Women in Clinical Trials. This webinar series will provide clinical researchers with methods and tools to assist them as they plan for successful outreach to diverse populations of women.

Planning for Diversity – November 1, 2016Recruitment and Retention – November 9, 2016

In addition to this series on diverse women in clinical trials, ACRP will offer a third webinar on November 16th on FDA’s Bioresearch Monitoring Program (BIMO) Compliance and Enforcement of Drugs and Devices.

Continuing education credits will be provided to all registered participants. Registration fees: $25 ACRP Members and $75 Non-Members

Register Now: https://www.acrpnet.org/diverse-women/

Breast Cancer Awareness Resources

Mammograms can help detect breast cancer when it is in its early, most treatable stages. Visit FDA’s mammography webpage for fact sheets, safety alerts, and other resources to help you educate other women about the importance of regular mammography screenings.

Find a certified mammography facility in your area.
Join OWH’s Pink Ribbon Sunday Program in promoting mammography awareness on October 23.
Learn about OWH-funded breast cancer and mammography research.

Medicine and Pregnancy Twitter Chat: October 27

FDA’s Office of Women’s Health (@FDAWomen) is joining @mytext4baby, @MotherToBaby, and other partners for a #FDAPregnancyChat on October 27 from 2-3 p.m. EDT. The chat will discuss medication use during pregnancy and other tips and resources for pregnant women.

Visit the Medicine and Pregnancy webpage

New Blog: Two Year Progress Update on FDASIA 907 Action Plan

Janice Soreth, M.D., Chair of the FDA Safety and Innovation Act (FDASIA) Section 907 Steering Committee and the Acting Associate Commissioner for Special Medical Programs, provides an update on the accomplishments made from the FDASIA 907 Action Plan.

Read the FDAVoice blog post

FDA Requesting Additional Nominations for Patient Representatives on its First Patient Engagement Advisory Committee

The FDA is requesting nominations for patient representatives to serve as voting members on its Patient Engagement Advisory Committee (PEAC). This committee will consist of patients and their care-partners. PEAC members will serve as a resource to the FDA in patient experience, needs, and the activities of a patient community. PEAC members also advise the Commissioner and the Agency on ways to incorporate the patient perspective on FDA decisions that may affect them.

Learn more about the Patient Engagement Advisory Committee

Read the Federal Register Notice