jueves, 14 de diciembre de 2017

Read about FDA Safety Alerts, Holiday Safety, and more

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Message from the Director
In 2017, the Office of Women’s Health focused on providing health and safety information tailored to the many roles women play in their daily lives. Whether you are a scientist, mother, health professional, student, or academic researcher, we have connected you to product decisions and safety information through our monthly updates and tailored email alerts. We have also lead scientific initiatives and supported various research efforts, by collaborating across the Agency to fund studies to advance the knowledge of sex and gender differences. In addition, we continued to connect women to health information through our Take Time to Care outreach initiative.

As we close this year, I want to thank you for your continued support and dedication to women’s health. It is because of you, our partners and stakeholders, that we are able to amplify messages to help keep women and their families safe. I encourage you to stay connected with us as you enjoy the holiday season and move into 2018. 
Marsha Henderson, Associate Commissioner for Women's Health
Women's Health Highlights
FDA Warns that Biotin May Interfere with Lab Tests: FDA Safety Communication
The FDA is alerting the public, health care providers, lab personnel, and lab test developers that biotin can significantly interfere with certain lab tests and cause incorrect test results which may go undetected. Biotin is found in multivitamins, including prenatal multivitamins, biotin supplements, and supplements for hair, skin, and nail growth in levels that may interfere with laboratory tests.

Read the Safety Communication
Proposed Reclassification/Renaming of Single-Use Female Condom
FDA has proposed to down classify the single-use female condom from a class III (highest risk) device to a class II (moderate risk) device. This is based on new scientific evidence recently reviewed by the agency indicating that these devices do not require the most stringent premarket review to provide a reasonable assurance of safety and effectiveness. FDA also proposes to rename the single-use female condom to “single-use internal condom” to indicate that the device can be inserted internally for vaginal or anal intercourse. There will be a 60-day comment period on the proposed order. Electronic or written comments on the proposed order can be submitted until February 2, 2018.

Read the Federal Register Notice and Submit Comments
FDA Approves First Two-Drug Regimen for Certain Patients with HIV
FDA recently approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 (HIV-1) instead of three or more drugs included in standard HIV treatment.

Read the News Release
Put Safety First this Holiday Season
Be prepared this holiday season with safety tips from FDA’s recent consumer updates. Share these holiday safety tips with your family and other caregivers in your community. 
Participate in Upcoming FDA Public Meetings
Webinar: HIV/AIDS in Older Americans- The Graying of The Disease 
December 18, 2017, 2:00 pm to 3:00 pm (EST)

Public Workshop on Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input
December 18, 2017, 9:00 am to 5:00 pm (EST)
FDA White Oak Campus, Silver Spring, MD

Public Workshop: Self-Collection Devices for Pap Test
January 11, 2018, 9:00 am to 4:00 pm (EST)
FDA White Oak Campus, Silver Spring, MD

Webinar: Ethnicity- and Gender-related Differences in Alzheimer’s Disease
January 11, 2018, 12:00 pm to 1:00 pm (EST)

Learn more about OWH staff presentations at national and international meetings and conferences.

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