FDA Office of Women's Health e-Update: September - October 2014

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

Title: FDA Office of Women's Health e-Update: September - October 2014

September - October 2014
www.fda.gov/womens

Message from the Director

We recently celebrated the 20th anniversary of the establishment of the Office of Women’s Health. As with most important milestones, we used this anniversary as an opportunity to reflect on the ways FDA has helped to improve women’s health in the past and how we can help bolster current and future scientific and educational activities for women. I encourage you to check out our timeline of some of FDA’s contributions to women’s health since 1994. Also, check this update for links to current FDA activities related to breast cancer, healthy aging, clinical trials, and more.

Marsha Henderson

Assistant Commissioner for Women’s Health

FDA Women's Health Highlights

Comment on FDASIA Section 907 Action Plan

On August 20, 2014, FDA issued a plan to enhance the collection and availability of clinical trial data on demographic subgroups – patient populations divided by sex, race/ethnicity or age. The plan includes 27 action items that are designed to meet three overarching priorities – improving the completeness and quality of demographic subgroup data collection, reporting and analysis (quality); identifying barriers to subgroup enrollment in clinical trials and employing strategies to encourage greater participation (participation); and making demographic subgroup data more available and transparent (transparency).  The public can submit comments until October 21, 2014. Read FDA’s Action Plan for FDASIA Section 907. Submit comments on the action plan.

Breast Cancer Month Resources

FDA is committed to supporting quality mammography and making effective treatments available for those living with breast cancer. During October, look to FDA for breast health resources. Our mammography webpage has links to fact sheets, alerts, and other helpful tips. The Pink Ribbon Sunday Mammography Awareness Program offers a planning guide and free materials to help community leaders educate women about mammography.

FDA’s Office of Minority Health and Patient Network provide information on ways women can participate in research on breast cancer treatments and other health conditions. Lastly, the Mammography Standards Act Program works to ensure that mammography facilities provide safe, reliable services.

Get the facts on mammography.

Search for a certified mammography facility in your area.

Follow OWH on Twitter to get mammography tips throughout October.

OWH's Healthy Aging Kit

In recognition of Healthy Aging Month, the Office of Women’s Health is offering a Healthy Aging Action Kit. The kit includes easy-to-read materials on common health issues older women face. It also includes a medicine record keeper and tips for safe medication use.  Order a Kit Today.

Extras

Get the facts on Decorative Contact Lenses

Wearing any kind of contact lenses, including decorative ones, can cause serious damage to your eyes if the lenses are not used correctly. Before you get ‘Halloween contacts’ or other decorative contacts, check these FDA resources for important safety tips.

Decorative Contact Lenses: Dos and Don’ts

Decorative Contact Lenses: Is your vision worth it?

Telling FDA: Why Contact Lens Adverse Events Matter (FDA on Medscape)

Report Problems to FDA's Medwatch

FDA has a new consumer-friendly form for reporting adverse events and other serious safety problems with a medicine, medical device, or food product.

Learn more about what types of problems to report.

Submit a report online.

FDA Meetings

Patient-Focused Drug Development for Idiopathic Pulmonary Fibrosis

September 26, 2014 - 1 p.m. to 5 p.m.

FDA White Oak Campus, Silver Spring, MD

View Meeting Announcement and Agenda.

 

Advisory Committee Meeting: Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee

October 16, 2014 - 8 a.m. to 5 p.m.

FDA White Oak Campus, Silver Spring, MD

View Meeting Announcement.

 

Public Meeting and Scientific Workshop on Female Sexual Dysfunction

October 27, 2014 – 12:00 p.m. to 5:00 p.m.

October 28, 2014 – 8:00 a.m. to 5:00 p.m.

 View Meeting Announcement.

 Register for the Meeting.

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OWH Conference Exhibits

National Alliance on Mental Illness - September 4-5 

Nurse Practitioners in Women’s Health – October 15-17 

North American Menopause Society – October 16-17 

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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