Read about Minority Women's Health and more

"FDA Office of Women's Health" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Mon, 11 Apr 2016 09:06:29 -0500

Title:     Read about Minority Women's Health and more

            April 2016
www.fda.gov/womens

            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 in 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

           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.

Read the Press Release
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.

View
the Meeting Announcement

           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.

                              Extras

           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.

Read
the “FDA and NIH Release a Draft Clinical Trial Protocol Template for Public
Comment” blog post

Submit
Comments Online

Minority Health Month Resources

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

Download women’s health materials in English, Spanish and 16 other languages.
Check out FDA’s Minority Health
     webpage.

Join the Pink Ribbon campaign and educate your
     community about mammograms. 
Watch ¡Nunca Mas! novela
     series
     and teach women about safe medication use.
Visit FDA en Español webpage.

            FDA Meetings

Streamlining
Good Manufacturing Practices (GMPs) for Hearing Aids

April 21, 8:30 am to 5:30 pm, FDA White Oak Campus

Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the 
Anesthetic and Analgesic Drug Products Advisory Committee Meeting 
Announcement
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

      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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