FDA Office of Women's Health Update Archive
The Office of Women's Health e-Update highlights women's health initiatives, meetings, and regulatory safety information from the U.S. Food and Drug Administration (FDA). The e-Update is disseminated via email to the public.
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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
Public Hearing on FDASIA Section 907
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.
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.
Celebrate 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.
National 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.
- 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