Read about Research Roadmap, Clinical Trials and more in the January FDA Women's Health eUpdate

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

Title: Read about Research Roadmap, Clinical Trials and more in the January FDA Women's Health eUpdate

January 2016
www.fda.gov/womens

Message from the Director

The Office of Women’s Health has exciting activities planned for 2016. We started the year by releasing the Women’s Health Research Roadmap that will help enhance the vital research being done at FDA. Later this month, we will launch the Diverse Women in Clinical Trials initiative as we continue to support FDA’s Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data. I encourage you to join us for the social media rally to kickoff this new initiative. I also hope you will continue to look to us in 2016 as we launch new research and outreach activities to advance women's health.

Marsha Henderson, Assistant Commissioner for Women’s Health

FDA WoMEN'S Health Highlights

New Women' Health Research Roadmap

OWH released a Women’s Health Research Roadmap that will further the development of new tools and approaches for informing FDA decisions about FDA-regulated products that are used not only by women, but by all Americans. Developed through cross-agency collaboration, the Roadmap outlines seven priority areas for new or enhanced research including biomarkers, clinical trials design, nanotechnology, cardiovascular disease, and postmarket surveillance. Read the Women’s Health Research Roadmap Read the new Blog on Advancing Women’s Health Research

Spread the Word about Women in Clinical Trials

Join the OWH Social Media Rally to show your commitment to encouraging clinical trials participation of diverse women who represent different ethnicities and ages, as well as those with various health conditions and disabilities. The rally will kick off OWH's new Diverse Women in Clinical Trials Initiative.

Sign Up Today. Help us Reach 2 Million Women!

Visit the Women in Clinical Trials Thunderclap page to sign up with your Facebook, Twitter, or Tumblr account.

A one-time only message will automatically be sent on Wednesday, January 27, 2016 at 1 pm ET from your account. Individuals and organizations can sign up.

Feb. 29 Public Meeting on FDASIA Section 907

FDA will conduct a public meeting to present the Agency's progress in implementing the “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,” required under Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA will also be seeking feedback and recommendations from stakeholder groups including woman's organizations, patient groups, consumer groups, regulated industry, and academia. If you would like to make oral presentations at the meeting, you must register by February 1, 2016 by emailing FDASIA907@xxxxxxxxxxx.

This meeting will be held on February 29, 2016 at FDA’s White Oak Campus in Silver Spring, MD. 

Register for the Meeting

Read Federal Register Notice

Read the “Progress and Collaboration on Clinical Trials” blog post

Extras

Webinar: Introduction to FDA’s MedWatch

On January 26, 2016 at 1pm (EST), FDA will host a webinar "Introduction to FDA’s MedWatch Adverse Reporting Program" for healthcare professionals and students on how to report adverse events to FDA MedWatch, and where to find clinically relevant information from Medwatch.

Register for the Webinar

Report a Serious Problem to FDA

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4 Ways to Kick Off a Healthy 2016

If you committed to choosing a healthier lifestyle in the New Year, FDA has resources to help you keep your resolutions. OWH has launched a new webpage to connect women with tips and tools they need to make healthy decisions.

Learn 4 Ways to Kick Off a Healthy 2016

Share the “4 Ways to Kick Off a Healthy 2016” pin on Pinterest

FDA Meetings

Public Workshop –Devices for Monitoring Warfarin Therapy

January 25, 2016 - FDA White Oak Campus, Silver Spring, MD

Patient Focused Drug Development Meeting: Psoriasis

March 17, 2016, 10:00 am to 6:00 pm, Location TBD

How Should Liver Injury and Dysfunction Caused by Drugs Be Measured, Evaluated, and Acted Upon in Clinical Trials? (co-sponsored by FDA Center for Drug Evaluation and Research)

March 23-23, 2016 - College Park Marriott Hotel & Conference Center, MD

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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