December Women's Health Update

["FDA Office of Women's Health" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: December Women's Health Update

December 2016

www.fda.gov/womens

Message from the Director

As we end another year, I want to thank all of you for supporting the vital work FDA has done in 2016 to advance women�s health. OWH started the year with the launch and implementation our new Women�s Health Research Roadmap and our national Diverse Women in Clinical Trials Initiative both of which are helping the Agency to better understand product safety for women and men, as well as, spur innovation in clinical trials design and recruitment. Throughout the year, we have funded important research, conducted workshops and trainings for FDA reviewers and the public, and provided FDA health and safety information to women from all backgrounds including caregivers, college students, pregnant women, and older adults. With the support of government and private partners like you, we have reached millions throughout the U.S. I encourage you to learn more about the impact of OWH-funded research and visit our website for patient education materials, outreach toolkits, and digital resources.

I hope that you will continue to look to us in 2017 for monthly updates highlighting new product alerts, workshops, and other program news for women and their families. The look of our emails may have changed but our commitment to protecting the health of women and their families remains the same.

Marsha Henderson, Assistant Commissioner for Women�s Health

WOMEN�S HEALTH HIGHLIGHTS

FDA grants accelerated approval to new treatment for advanced ovarian cancer

FDA today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test.�

Read the News Release

FDA issues new warnings about using general anesthetics and sedation drugs in young children and pregnant women

FDA is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children�s brains.�To better inform the public about this potential risk, we are requiring warnings to be added to the labels of general anesthetic and sedation drugs.

Read the Safety Announcement

New Winter 2017 Diverse Women in Clinical Trials Partner Toolkit

OWH�s Diverse Women in Clinical Trials Awareness Campaign continues to raise awareness about the importance of women in clinical trials. Use our new partner toolkit to spread the word and educate women in your network. The toolkit includes sample social media resources that can be used during winter health observances and throughout the year.

Download the Women in Clinical Trials Toolkit

Visit the Diverse Women in Clinical Trials webpage

New Mammography Quality Initiative: EQUIP

The quality of mammogram images is one of the most important determinants of the accuracy of mammography. FDA�s new EQUIP (Enhancing Quality Using the Inspection Program) initiative aims to address clinical image quality as a part of the annual inspections of mammography facilities. Facilities must have a system in place to ensure that images continue to comply with the clinical image quality standards established by the facility�s accreditation body. The EQUIP initiative was introduced on October 27, 2016, the beginning of the 25th year since the passage of the Mammography Quality Standards Act (MQSA). Inspections containing EQUIP questions will begin January 1, 2017.�

Learn more about the EQUIP Initiative

Read the MQSA Insights article on EQUIP

Extras

What to Ask Your Doctor Before Taking Opioids

Every patient should ask questions when getting a new prescription. This is especially important when your doctor, dentist or other health care professional prescribes you an opioid, such as hydrocodone, oxycodone, codeine and morphine. Learn what questions to ask to keep you and your family safe.�

Read the Consumer Update

Learn More about Opioid Pain Medications

Meetings

Ninth Annual Sentinel Initiative Public Workshop

February 2, 2017, 9:00 am to 4:30 pm

Barbara Jordan Conference Center, Washington, DC

Please share this update with your network, members, constituents, and community.
FDA Office of Women's Health,�owh@xxxxxxx, 301�796�9440
10903 New Hampshire Avenue, WO32�Room 2333, Silver Spring, MD 20993

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