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. |
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.
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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. |
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. |
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.
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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.
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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. |
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 D |
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