FDA Office of Women's Health May 2015 e-Update

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

Title: FDA Office of Women's Health May 2015 e-Update

Celebrate National Women's Health Week

May 2015
www.fda.gov/womens

Message from the Director

During National Women’s Health Week, I encourage you to connect the women in your community to FDA information on safe medication use, pregnancy, mammograms, and other vital health topics. Check this update for links to a variety of digital and print resources that you can use for your women’s health events and clinical services. I also encourage you to join us and the NIH Office of Research on Women’s Health for a panel workshop on women in clinical trials on May 14th at the NIH campus in Bethesda. From the 2001 GAO Report to FDA’s own internal studies, we see that there has been improvement in the participation of women in studies for new drug applications – for both early and late phase trials. While we have made great strides in the inclusion of women, we also know that more can be done to help increase the participation of women from diverse backgrounds, ages, and ethnicities to participate. This workshop is just one of many opportunities for you to join us in meaningful dialogue about continuing the progress we have made in this area.

Marsha Henderson

Assistant Commissioner for Women’s Health

women's health highlights

National Women's Health Week: May 10-16

Throughout the week, use these FDA resources to promote healthy living for women at every stage of life. Use OWH health materials in English, Spanish, and 18 Other Languages for your events. Share our 4 tips to help avoid common medication mistakes. Follow @FDAWomen on Twitter for tips and resources. Schedule your mammogram. Check FDA’s website for a certified facility.

Counterfeit Version of Botox Found in the U.S.

FDA is alerting health care practitioners and the public that a counterfeit version of Botox was found in the United States and may have been sold to doctors’ offices and medical clinics nationwide.  The product was sold by an unlicensed supplier who is not authorized to ship or distribute drug products in the United States. The counterfeit products are considered unsafe and should not be used. Find out how to identify the counterfeit product and report suspect Botox products to FDA.

Risk Communication Advisory Committee Meeting: Communicating Fetal Effects for Treatment for Opioid Addiction

On June 8 and 9, 2015, the Committee will discuss approaches to communicating information about fetal effects in product labeling for methadone or buprenorphine maintenance therapy for opioid addiction, and about the maternal benefits and risks of treatment, to best enable patients and healthcare providers to make informed decisions about the use of these drugs during pregnancy. The meeting will be held at the FDA White Oak Campus in Silver Spring, MD.  View the Meeting Announcement.

Extras

New FDA Draft Guidance on Acceptance of Medical Device Clinical Data from non-U.S. Studies

This draft guidance articulates FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for devices. The guidance describes special considerations that apply when using such data, including applicability of the data to intended patient populations within the United States and study design issues, and also provides recommendations to assist sponsors in developing data that are adequate under applicable FDA standards to support approval or clearance of the device in the United States. This guidance is not intended to announce new policy, but to describe FDA’s existing approach to this topic.

Read the Draft Guidance (PDF 648KB).

FDA Meetings

Public Workshop: Meet the Faces of Clinical Research: Beyond Inclusion

May 14, 2015 from 10-12 a.m.

NIH Lipsett Amphitheater, Bethesda, MD

 

FDA Science Forum

May 27-28, 2015

FDA White Oak Campus, Silver Spring, MD

Registration ends May 15

OWH Conference Calendar

The Office of Women’s Health exhibits and presents at conferences across the country to increase awareness of FDA’s women’s health resources and programs. Check out an OWH exhibit booth or presentation at one of these conferences:

American College of Obstetricians and Gynecologists, May 2-6 – San Francisco, CA

AARP, May 14-16 – Miami, FL

National Osteoporosis Foundation, May 19-22 – Washington, DC

American College Health Association, May 26-30 – Orlando, FL

YWCA, June 4-6 – 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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