Read about Menopause, Healthy Aging and more

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September 2017

Message from the Director

OWH helps to advance women’s health by leading scientific initiatives and connecting health professionals and every day women of diverse ages and backgrounds to the latest FDA safety information, news and activities. This month, we are hard at work promoting healthy habits to help women age well, celebrating Hispanic women’s heritage and health, and providing tips for women managing menopause. We are also collaborating with other FDA programs to better understand and promote the participation of women and other demographic groups in clinical trials. I encourage you to read the new report on global participation in clinical trials and get involved with our outreach initiatives.    In addition, I want to recognize an amazing pioneer and OWH partner in women’s health research, Dr. Vivian Pinn, for her leadership in addressing all of the areas cited above. As a result, her alma mater has honored her with a building in her name to inspire innovation in medical research for years to come.   Marsha Henderson, Assistant Commissioner for Women's Health

FDA approves first biosimilar for the treatment of cancer

The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers. Read the News Release.

FDA approves new drug for bacterial vaginosis

FDA approved a new medication for bacterial vaginosis. This treatment is the first one-dose oral regimen for the most common vaginal infection in women 15-44 years of age. To learn more, visit: Solosec.

New Guidance for Medical Device Clinical Studies

FDA issued new guidance entitled, “Evaluation and Reporting of Age, Race, and Ethnicity Data in Medical Device Clinical Studies.'' The primary intent of these recommendations is to improve the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, race, and ethnic groups. This guidance is one of the 27 action items laid out in the 907 action plan for FDASIA. Read the Guidance Document.

September is Menopause Awareness Month

Many women have questions about managing symptoms that arise before, during, and after menopause. Check out our updated Menopause webpage for resources and use our Menopause Partner Toolkit to encourage women in your community to stay informed about menopause and talk to their healthcare providers about treatment options. Visit the updated Menopause webpage. Download our new Menopause Partner Toolkit.

Hispanic Heritage Month Resources

Hispanic Heritage Month is September 15 - October 15, 2017. Celebrate Hispanic women’s heritage by sharing FDA’s Spanish-language fact sheets,  ¡Nunca Más! Novelas, and other resources to encourage Hispanic women to live healthier lives. Visit the Hispanic Women’s Health webpage.

October 15th is #PinkSunday. How will you participate?

The Pink Ribbon Sunday Mammography Awareness Program educates women about early detection of breast cancer through mammography. Show your support on #PinkSunday (October 15, 2017) by wearing something pink and sharing FDA resources with women in your community. Visit the Pink Ribbon Sunday Program webpage to learn how to get involved. Order free Mammograms fact sheets in English and Spanish for your events and outreach.

Get the Facts about Generic Drugs

FDA launched an educational campaign aimed at raising awareness among Americans about the value of generic drugs. The campaign will include resources for consumers and health professionals. Visit the Generic Drugs webpage.

FDA Public Meetings

Public Meeting on Patient-Focused Drug Development for Hereditary Angioedema September 25, 2017, 9:00 am to 3:00 pm FDA White Oak Campus, Silver Spring, MD   Public Workshop: Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review October 2, 2017, 8:00 am to 4:30 pm October 3, 2017, 8:00 am to 4:00 pm FDA White Oak Campus, Silver Spring, MD   Advisory Committee Meeting: Patient Engagement October 11, 2017, 1:00 pm to 5:00 pm October 12, 2017, 8:00 am to 5:00 pm Hilton Washington DC North, Gaithersburg, MD

Replying to this message will not reach the OWH staff. If you have comments or questions, please contact us at 301-796-9440 or owh@xxxxxxx.  For additional women's health information, please visit the For Women webpage .

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