domingo, 15 de enero de 2017

New Look: January Women's Health Update

u s food and drug administration

Message from the Director

The Office of Women’s Health is committed to promoting and protecting the public’s health. In this New Year of 2017, we will do even more to provide you with timely product safety information, scientific research updates and health resources tailored to the many roles women play in their daily lives. Whether you are a scientist, caregiver, health professional, student or academic researcher, we will be working to connect you with new data, product decisions, and safety information through this update and through targeted email alerts.
We are kicking off the year with new medication safety resources for pregnant women and their healthcare providers. As you observe National Birth Defects Month, I encourage you to visit our updated Medicine and Pregnancy webpage for tips and tools expectant mothers can use to make informed decisions about their medicines. Be sure to check out the other pregnancy resources in this update and the announcements for upcoming webinars and workshops on topics ranging from clinical trials to e-cigarettes.
Lastly, I want to start the year by asking each of you to help us reach women from urban and rural communities across the country. Link to FDA’s women’s health web content and share our messages on Twitter and Pinterest. Join one of our campaigns. Help us spread the word. We can’t do this work without you.
Marsha Henderson, Assistant Commissioner for Women’s Health

New Pregnancy Toolkit

As a part of our ongoing Resources for You and Your Baby outreach initiative, OWH offers resources to help women and healthcare providers get informed about medicines and other products used during pregnancy. Our new Medicine and Pregnancy toolkit features sample messages for you to use in your outreach and on social media outlets like Facebook and Twitter. Help share these pregnancy resources with the women in your community. Use the sample social media posts and announcements in this toolkit to help women and their healthcare providers have a conversation about pregnancy safety.
Download the FDA Pregnancy Toolkit
Print and share the Medicine and Pregnancy Fact Sheet in English and Spanish

Adding Folic Acid to Corn Masa Flour May Prevent Birth Defects

Educate Latinas in your community about the importance of folic acid for birth defects prevention. The FDA moved to help protect Latinas and their children by approving the addition of folic acid to corn masa flour, an ingredient in foods including tortillas, tacos, tortilla chips and tamales. Foods made from this flour are staple foods of Mexican and some Central and South American diets. When consumed by pregnant women before and during pregnancy, folic acid—a B vitamin—may help to prevent neural tube defects.

Confirmatory Testing Needed for Zika Serological IgM Test

FDA is alerting physicians that the U.S. commercial testing facility, Laboratory Corporation of America (LabCorp) has reported some false positive results from the ZIKV Detect™ IgM Capture ELISA test.
FDA urges health care providers to inform patients that presumptive positive results need to be confirmed, so that pregnant women are not making health care decisions based on incomplete information.
IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing.

FDA Grand Rounds on Nanotechnology: Jan 12th

Tune in to FDA’s Grand Rounds, web cast live on Thursday, January 12, 2017 from 12-1 p.m., EST to learn about FDA’s research on nanoparticles that are used in consumer and medical products like cancer treatments, dietary supplements, and sunscreen. Dr. Thilak Mudalige of FDA’s Office of Regulatory Affairs will be presenting, “Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products.”

CDC Grand Rounds on Opioid Use Disorder in Women

Join CDC on Tuesday, January 17, 2017 at 1:00 p.m. (EST) to discuss how health care providers, researchers, and the public health community can best address the complexities of opioid use disorder among women. Speakers will give an overview of the federal response to the disorder, along with approaches to care and prevention of substance use.  A live external webcast will be available via the Webcast Links section at the time of the event.

FDA Public Workshop on Battery Safety Concerns in Electronic Nicotine Delivery Systems (ENDS)

The FDA will host a two-day public workshop on April 19-20, 2017, in Silver Spring, MD, to gather information and stimulate discussion on battery safety concerns (overheating, fires, explosions, etc.), reducing the risk of incidents, and design parameters related to electronic nicotine delivery systems (ENDS), including e-cigarettes.
In addition, a public docket has been established to receive written comments to gather information on hazards and risks associated with the use of batteries in ENDS.

Guidance Webinar: Collection of Race and Ethnicity Data in Clinical Trials

January 24, 2017, 12:00 pm to 1:00 pm
February 2, 2017, 9:00 am to 4:30 pm
Barbara Jordan Conference Center, Washington, DC

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