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October 2018 Office of Women's Health e-Update

mature woman holding a medicine bottle and looking up information

Message from the Director

This month, FDA recognizes Talk About Your Medicines Month by discussing the important topic of safe medication use. According to the Centers for Disease Control and Prevention (CDC), more than 70% of American women over age 45 say they take at least one prescription medicine. I encourage you to read “Women’s Safe Medicine Use: Q & A” for a discussion about safe medication use and tips to help women and their families avoid common medication mistakes and mistakes which may lead to addiction.

The “Women’s Safe Medicine Use: Q & A” follows the momentum of our dynamic two-day scientific conference, “Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender”. I would like to extend an enormous thank you to the Center for Drug Evaluation and Research and the Center for Tobacco Products for their collaboration and support of this scientific conference. Simultaneously, I would like to thank Deputy U.S. Surgeon General, RADM Sylvia Trent-Adams, and FDA Commissioner Dr. Gottlieb and for their support as well as the Executive Steering Committee, Scientific Planning Committee, speakers, and attendees. I encourage you to view and share the webcast recording of this scientific conference widely with your networks as we continue conversations around the influences of sex and gender differences.

Marsha Henderson, Associate Commissioner for Women's Health

Women's Health Highlights

FDA approves expanded use of Gardasil 9 to include individuals 27 through 45 years old
The U.S. Food and Drug Administration approved a supplemental application for Gardasil 9 (Human Papillomavirus (HPV) 9-valent Vaccine, Recombinant) expanding the approved use of the vaccine to include women and men aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by the nine HPV types covered by the vaccine.

FDA takes steps to improve mammography quality and empower patients with more information about their health

The FDA intends to propose a new rule that will modernize mammography quality by recognizing new technologies, making improvements in facility processes and updating reporting requirements. The agency is proposing updates that incorporate current science and mammography best practices, including addressing breast density reporting by mammography facilities to patients and health care providers. These updates are intended to improve the delivery of mammography services.

FDA approves new DNA-based test to determine blood compatibility

The U.S. Food and Drug Administration approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types.

FDA allows marketing of first self-fitting hearing aid controlled by the user The U.S. Food and Drug Administration allowed marketing of a new device, the Bose Hearing Aid, intended to amplify sounds for individuals 18 years or older with perceived mild to moderate hearing impairment (hearing loss). This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider.

FDA takes important steps to encourage appropriate and rational prescribing of opioids through final approval of new safety measures governing the use of immediate-release opioid analgesic medications The U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals.

Call To Action

National Prescription Drug Take Back Day is October 27, 2018.
When your medicines are no longer needed, they should be disposed of promptly. Learn how to dispose of unused and expired drugs safely.

Mammography Resources
Did you know FDA regulates the standards for mammography machines and training for the people who provide mammograms? This National Breast Cancer Awareness Month, learn how FDA helps you and the women in your community.

Participate in Upcoming FDA Meetings

The Keys to Success in Clinical Research; Becoming a Trusted Entity in Diverse Communities is the Key to Success in Clinical Research
October 22, 2018, 2:00 pm to 3:00 pm

Regulatory Education for Industry (REdI): FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials – Are We There Yet?
October 23 – 24, 2018
Tommy Douglas Convention Center, Silver Spring, MD

FDA Public Workshop: Clinical Trials to Optimize Outcomes in Early Breast Cancer
October 29, 2018, 8:30 am to 4:15 pm
FDA White Oak Campus, Silver Spring, MD

Regulatory Education for Industry (REdI): FDA Clinical Investigator Training Course (CITC) 2018  
November 13 – 15, 2018
Tommy Douglas Convention Center, Silver Spring, MD

FDA Public Workshop: Partners in Progress 2018 – Cancer Patient Advocates and FDA.
November 27, 2018, 9:00 am to 4:00 pm
FDA White Oak Campus, Silver Spring, MD

Visit an OWH exhibit booth or presentation at these upcoming conferences.

American Public Health Association (APHA) Annual Meeting
November 10 – 14, 2018, San Diego, CA

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