FDA Office of Women's Health March e-Update

["FDA Office of Women's Health" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA Office of Women's Health March e-Update

March 2014
www.fda.gov/womens

Message from the Director

In recent weeks, there has been renewed interest in women’s health and sex differences. Women’s History Month affords us the opportunity to recognize the tremendous progress that has been made and to work together to address the ongoing health issues that impact women and their families. I encourage you to check out this e-Update for upcoming public meetings where you can dialogue with the Agency, ways to submit comments on proposed FDA regulations, and HIV resources that you can share in your community.

Marsha Henderson

Assistant Commissioner for Women’s Health

FDA Women's Health Highlights

FDASIA Section 907 Public Hearing

FDA will be holding a public hearing on April 1, 2014 to obtain input on the issues and challenges associated with the collection, analysis, and availability of demographic subgroup data in applications for approval of FDA-regulated human medical products. If you wish to attend the hearing or make an oral presentation during the hearing, you must register by submitting either an electronic or written request by March 21, 2014.

Register for the FDA Public Hearing: FDASIA Section 907

View the Meeting Announcement and Submit Comments

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Public Meeting on Pregnancy Exposure Registries

Pregnancy exposure registries are observational studies on women who take medicines during pregnancy. FDA will be holding a public meeting on May 28 – 29, 2014 to obtain information on methods for evaluating the safety of drugs and biological products during pregnancy in the post-approval setting. The input from this meeting and public docket will be used to support the revision of a guidance for industry on establishing pregnancy exposure registries.

View the Meeting Announcement and Submit Comments

Women's History Month

Throughout the month of March, we recognize pioneering women who have made significant and long-lasting contributions to public health during their careers with FDA. Check out these resources to learn more about these notable women, as well as, the Agency’s efforts throughout its 100+ year history to protect and promote women’s health.

Learn about notable women leaders at FDA. 

Download the FDA Milestones in Women’s Health history booklet.

Read the oral history from Jane Henney – FDA’s first female Commissioner.

View photos from FDA History on flickr.

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Women and Girls HIV/AIDS Awareness Day

On March 10th, use FDA resources to educate the women in your community about HIV testing and treatment.

Download a HIV fact sheet or medicine booklet.

Read about FDA’s HIV and AIDS activities.

Learn how you can get involved with National Women and Girls HIV/AIDS Awareness Day.

Extras

FDA Resources on Medscape

FDA has an ongoing collaboration with Medscape to connect clinicians with information on a range of health topics. Check out these commentaries from FDA experts:

Acetaminophen, Opioids, and Safety

Drugs and the Breastfeeding Mother: A New Clinical Report

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Proposed Changes to Food Labels

FDA wants to update the look and content of the Nutrition Facts on food labels to help consumers make informed food choices. FDA has also proposed changes to the definition of serving sizes of foods.

Review the proposed changes to food labels and submit comments

Other FDA Events

Microbiology Devices Panel of the Medical Devices Advisory Committee

March 12, 2014 – College Park Holiday Inn

  

Public Meeting on Fibromyalgia Patient-Focused Drug Development

March 26, 2014 – FDA White Oak Campus

 

Please share this update with your network, members, constituents, and community

FDA Office of Women's Health
10903 New Hampshire Avenue
WO32 - Room 2333
Silver Spring, MD 20993*0002
301-796-9440

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