For Consumers

FDA Office of Women's Health Update Archive



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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.

Current Issue:  April 2016

Message from the Director

During the month of April, we take time to celebrate women of all cultural and linguistic backgrounds. It is important to recognize that each and every woman is different. At FDA we make diversity a priority. One way we celebrate diversity is by ensuring health messages are available is a variety of languages. I encourage you to view our publications in other languages and FDA’s Minority Health webpage. We hope that you will share the important product safety information, consumer resources, and meetings highlighted in this update so that women from diverse communities will benefit from FDA resources and activities. 
Marsha Henderson - Assistant Commissioner for Women’s Health

FDA Women’s Health Highlights

FDA allows marketing of first-of-kind tissue containment system for use with certain laparoscopic power morcellators in select patients

FDA permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer.
Although the device is an effective tissue containment system, the FDA is requiring the manufacturer to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.

Public Workshop on Lactation

On April 27 and 28, 2016, FDA’s Division of Pediatric and Maternal Health will hold a public meeting on the evaluation of the safety of drugs and biological products used during lactation.
The purpose of this 2-day workshop is to provide a forum to discuss the current state and future directions of the collection of data on the potential risks to breastfed infants with maternal use of medications during lactation.

Minority Women’s Health Twitter Chat: April 19

Join FDA’s Office of Women’s Health (@FDAWomen), FDA’s Office of Minority Health (@FDAOMH) and FDA en Español (@FDAenEspanol) for a #FDAHealthChat on Twitter on April 19 from 1-2 p.m. EDT.
This bilingual chat will focus on tips minority women can use to live a healthier life. It will also highlight how to empower diverse women to take control of their health.


FDA and NIH Release a Draft Clinical Trial Protocol Template for Public Comment

The clinical trial protocol is a critical component of any medical product development program. NIH and FDA are seeking public comment on a new draft template for NIH funded investigators to use in writing protocols for phase 2 or 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications.  Researchers and other stakeholders are encouraged to submit comments through April 17, 2016.

Minority Health Month Resources

Look to FDA for resources to support your outreach to women of all diverse cultural backgrounds.

FDA Meetings

April 21, 8:30 am to 5:30 pm, FDA White Oak Campus
May 3-4, 8:00 am to 5:00 pm, FDA White Oak Campus

OWH Conference Exhibits

Public Library Association Conference - April 5-9, Denver, CO
National Indian Health Board Tribal Public Health Summit - April 11-13, Atlanta, GA
Southern Women's Show - April 14-17, Nashville, TN
Annual Congress on Women's Health - April 14-17, Washington, DC
Association of Clinical Research Professionals - April 16-19, Atlanta, GA
National Hispanic Medical Association - April 21-25, Washington, DC


Contact FDA

Food and Drug Administration Office of Women's Health

10903 New Hampshire Avenue


Silver Spring, MD 20993

Page Last Updated: 04/14/2016
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