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January 2018 Office of Women's Health e-Update

Message from the Director

It’s a new year and the Office of Women’s Health is excited to continue advancing science and innovation to improve the health of women and their families. As we look ahead, OWH will prioritize initiatives that support the 2018 Strategic Policy Roadmap, led by Commissioner Dr. Gottlieb, to advance FDA’s public health mission. 

We began the year by continuing to empower women to make better and more informed decisions about their health by committing to healthy habits. We have also continued to connect pregnant women, new mothers, and their healthcare providers to safety resources through our Resources for You and Your Baby Initiative. As you observe National Birth Defects Prevention Month, I encourage you to visit our Medicine and Pregnancy webpage and share the resources in this update to help pregnant women start a conversation with their healthcare providers about the medicines they take. 

I hope you will continue to look to us in 2018 as we advance the understanding of women’s health issues, launch new research, and lead outreach activities to help women make safe and healthier choices about FDA products. We depend on each of you to help us amplify these important messages to women across the country. Please link to FDA’s women’s health web content and share our messages on Twitterdisclaimer icon, Pinterest disclaimer iconand in your newsletters. You are a key part of helping us improve the health of women.
Marsha Henderson - Associate Commissioner for Women’s Health

Women’s Health Highlights

Resources for Pregnant Women
January is National Birth Defects Prevention Month. Encourage expectant mothers to make informed decisions about their medicines with these FDA resources. 
FDA Approves First Treatment for Breast Cancer with a Certain Inherited Genetic Mutation
FDA expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation.
Prescription Opioid Cough and Cold Medicines: FDA Requires Label Changes
FDA is requiring safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone to limit the use of these products to adults 18 years and older. The Agency has determined that the risks of these medicines outweigh their benefits in children younger than 18. FDA is also requiring the addition of a “Boxed Warning” with safety information about the risks of misuse, abuse, and addiction leading to overdose, death, and slowed or difficult breathing.  
FDA's New Patient Engagement Collaborative
The FDA and the Clinical Trials Transformation Initiative (CTTI) will be working together to create a new work group with patient advocacy organizations to talk about patient engagement at the FDA.
Advancing Health through Innovation: New Drug Therapy Approvals of 2017
FDA released Advancing Health through Innovation: New Drug Therapy Approvals of 2017, a summary of the Center for Drug Evaluation and Research’s (CDER’s) 2017 important new drug approvals that serve to advance public health. These approvals will benefit patients affected by a wide range of rare diseases, neurological conditions, infectious diseases, cancers, and many other medical conditions.

Call to Action

New Website Survey: Give Us Feedback
Tell us about your experience using the For Women section of FDA’s website. A feedback button has been added to select women’s health webpages to gather information that we can use to improve our web content. 
Kick Off a Healthy New Year
Commit to a healthier you in 2018. Get started with our 4 tips to help you and your family build healthy habits. 
Tips to Quit Smoking
FDA has tips to help women quit smoking. Use these FDA resources to help you and others in your community make a plan to quit smoking. 
It's Not Too Late to Get Your Flu Shot
Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one. An annual seasonal flu vaccine is the best way to reduce your risk of getting sick and spreading it to others.


Participate in upcoming FDA Public Meetings.
January 30, 2018, 8:30 am to 4:30 pm (EST)
FDA White Oak Campus, Silver Spring, MD
February 7 – 8, 2018
Webcast and Presentation Slides are available for the Public Workshop: Self Collection Devices for Pap Test, held on January 11, 2018.
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