FDA Office of Women's Health - May e-Update

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

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

May 2014
www.fda.gov/womens

Message from the Director

Once again, we take time out to celebrate National Women’s Health Week – May 11-17. It is a time to encourage women to make informed health choices. Look to FDA for educational tools to help women at every stage of their adult lives—covering topics that range from college health to healthy aging. We also provide resources to help scientists and health professionals better understand the unique health issues impacting women. Whatever your perspective, I encourage you to check out the links in this update and share the health tips, meeting announcements, and safety alerts with your networks.

Marsha Henderson

Assistant Commissioner for Women’s Health 

FDA Women's Health Highlights

Resources for National Women's Health Week

Celebrate National Women’s Health Week by participating in one of OWH’s activities or sharing FDA resources with the women in your community. Order a free kit of OWH materials. Follow us on Pinterest for a special challenge and health tips each day of the week. Read our latest blog on FDA’s women’s health resources. Visit FDA’s Women’s Health webpage for videos, health materials, and other tips.

2014 OWH Research Awards

After an internal and external peer-review process, the Office of Women’s Health has selected thirteen research projects for funding through our Intramural Science Program. The outcomes of these projects will help FDA develop innovative approaches to identifying and addressing the impact of sex on product safety and efficacy. Congratulations to the awardees and to all the applicants for their very high quality proposals. View the list of OWH-funded research projects.

May 16 Deadline to Submit Comments on the FDASIA 907 Action Plan

Section 907 of the Food and Drug Administration Safety and Innovation directed FDA to report on the extent to which demographic subgroups (sex, age, race and ethnicity) participate in clinical trials in marketing applications for drugs, biologics, and devices. The final report was posted in August 2013.  Section 907 also requires that FDA develop an Action Plan no later than one year following publication of the report. Public comments on the Action Plan will be accepted until May 16, 2014. Submit Comments.

Extras

Surgical Mesh for Transvaginal Pelvic Organ Prolapse

On April 29, FDA issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

Submit comments on the two proposals by July 30, 2014.

FDA: Proposed Order - “Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation” 

FDA: Proposed Order - “Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair”

FDA Meetings

Health Professional Organizations Annual Conference

May 14, 2014 – FDA White Oak Campus

Public Meeting on Pregnancy Exposure Registries

May 28-29, 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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