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March 2018 Office of Women's Health e-Update

Message from the Director

 
During Women’s History Month, we reflect on the accomplishments of the women who have contributed to FDA’s mission of protecting the public’s health. From field inspectors to scientists, these innovative women have paved the way for future generations in science, technology, engineering and mathematics (STEM). I encourage you to delve into the stories of these trailblazers by reading FDA’s Voices of Innovation: Women in Science, Technology, Engineering and Mathematics. We also acknowledge the contributions of our partners who are also innovators and pioneers in public health.
 
In this eUpdate, you will find recent FDA actions that continue this theme of excellence. For example, take a minute to read about FDA’s recent approval of the smallest heart valve in the world. In addition, I hope that you will share our safety messages and opportunities to participate in upcoming public meetings with your network. Every one of us can make a difference by continuing the legacy of protecting and promoting the health of women and their families.
 
Marsha Henderson - Associate Commissioner for Women’s Health
 
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Women’s Health Highlights

FDA authorizes, with special controls, a direct-to-consumer test that reports three mutations in the BRCA breast cancer genes.
FDA authorized the Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants). It is the first direct-to-consumer (DTC) test to report on three specific BRCA1/BRCA2 breast cancer gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent. These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population.
 
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Statement from FDA Commissioner on Essure.
FDA Commissioner Scott Gottlieb, M.D., outlines the steps FDA has taken, to date, regarding Essure, and the additional steps that are underway.
 
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FDA approves new HIV treatment for patients who have limited treatment options.
FDA approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV). Trogarzo is administered intravenously once every 14 days by a trained medical professional and used in combination with other antiretroviral medications.
 
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FDA expands approval of replacement heart valve, smallest mechanical valve size approved in the world.
FDA expanded the approval of a heart valve to include a size small enough to be used in newborn pediatric patients to treat heart defects. Specifically, the agency approved the Masters Series Mechanical Heart Valve with Hemodynamic Plus (HP) Sewing Cuff to include the 15-mm valve size, making it the smallest mechanical heart valve approved in the world.
 
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FDA warns of fraudulent and unapproved flu products.
As part of the FDA’s ongoing efforts to protect consumers from health fraud, the agency is reminding consumers to be wary of unapproved products claiming to prevent, treat or cure influenza, or flu. This year’s severe flu season raises new concerns about the potential for consumers to be lured into buying unproven flu treatments, and even worse, buying counterfeit antivirals online from websites that appear to be legitimate online pharmacies.
 
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Call to Action

 
Share Spring Break Resources.
Encourage young women to have a safe spring break. Share tips about sun safety, safe medication use, and more.
 
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Meetings

 
Participate in Upcoming Meetings.
 
Public Workshop on Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data
March 19, 2018, 1:00 pm to 5:00 pm (EST)
FDA White Oak Campus, Silver Spring, MD
 
Public Meeting: Promoting the Use of Complex Innovative Designs in Clinical Trials
March 20, 2018, 8:30 am to 5:00 pm (EST)
FDA White Oak Campus, Silver Spring, MD
 
Public Meeting: Evaluating Inclusion and Exclusion Criteria in Clinical Trials
April 16, 2018, 8:30 am to 5:00 pm (EST)
National Press Club, 529 14th St. NW, Washington, DC 20045
  
Public Meeting on Patient-Focused Drug Development for Opioid Use Disorder
April 17, 2018, 10:00 am to 4:00 pm (EST)
FDA White Oak Campus, Silver Spring, MD
 
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Visit an OWH exhibit booth or presentation at these upcoming conferences.
  
American Pharmacists Association Annual Meeting (APhA)
March 16 - 19, 208, Nashville, TN
 
National Alliance for Caregiving
March 26, 2018, San Francisco, CA
 
Aging in America - American Society on Aging
March 26-29, 2018, San Francisco, CA
 
 
Learn more about OWH staff presentations at national and international meetings and conferences.