Read about Essure, Caregiving and more

November 2016
www.fda.gov/womens

Message from the Director

During this time of thanksgiving, I want to thank the partners and individuals who have continued to share FDA health and safety information with their networks and communities. Thank you for supporting activities like our Diverse Women in Clinical Trials campaign as well as our Diverse Women in Clinical Trials Webinar Series. I hope you continue to look to us for resources on FDA-regulated products.

In November, I also want to recognize National Family Caregiver Month and American Diabetes Month. Caregiving and diabetes impact the lives of many women on a daily basis. I encourage you to visit our Tips for Caregivers webpage for information to help women manage the care of loved ones. Our Women and Diabetes webpage provides videos, publications and other tools that you can use to educate women on the safe use of FDA-approved medicines and medical devices for diabetes management. Use these important resources along with the FDA activities highlighted in this e-Update to connect with the women in your community and clinical services.

Marsha Henderson, Assistant Commissioner for Women’s Health

FDA WOMEN'S HEALTH HIGHLIGHTS

FDA approves Essure labeling with important safety information for patients and physicians. On November 15, 2016, the U.S. Food and Drug Administration approved important labeling changes for Bayer Healthcare’s Essure permanent birth control device and completed our investigation of the trade complaint regarding allegations first made in a Citizen Petition. Bayer revised the physician instructions for use and patient labeling consistent with FDA’s recently finalized guidance: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization.  Read the Announcement Read the Guidance Read the Consumer Update Get Essure Information for Patients FDA approves Intrarosa for postmenopausal women experiencing pain during sex. The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). Read the Press Release

Caregiving Resources for Women This Caregiving Month, visit FDA’s Tips for Caregivers webpage for resources to help caregivers manage medicines and other products for their loved ones. Celebrate all that caregivers do by sharing these tips with your family, friends and networks. Visit the Tips for Caregivers webpage

CDRH’s Patient and Care-Partner Connection The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is looking for public comment on the scope and nature of a new Patient & Care-Partner Connection program, intended to build upon our efforts at conducting meaningful patient engagement. Read the Federal Register Notice Learn more about the Patient and Care-Partner Connection

FDA Meetings Bone, Reproductive and Urologic Drugs Advisory Committee December 6, 8:00 AM to 5:00PM FDA White Oak Campus, Silver Spring, MD OWH Conference Exhibits Healthy Churches 2020 National Conference November 15-18, Charlotte, NC