February e-Update from the FDA Office of Women's Health

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: February e-Update from the FDA Office of Women's Health

February 2015
www.fda.gov/womens

Message from the Director

Heart disease in women is a top priority for the Office of Women’s Health. We fund research that has helped shape FDA guidance to industry and advanced knowledge about the diagnosis and treatment of cardiovascular diseases in women. We also conduct outreach campaigns to disseminate FDA safety alerts and easy-to-read publications to women in diverse communities nationwide. I encourage you to visit our Heart Disease Research and Heart Health for Women webpages to learn more about the work being done at OWH and across the Agency. Look to us over the coming year for new opportunities to collaborate on this important issue.

 

Marsha Henderson

Assistant Commissioner for Women’s Health 

FDA Women's health Highlights

Heart Health Resources

FDA has digital tools and easy-to-read publications on heart health for women. Throughout February, help spread the word about these resources and encourage the women in your community to live heart healthy lives. Visit our Heart Health for Women site for tips and resources. Follow our Heart Health board on Pinterest. Get the facts on using aspirin to prevent a heart attack. Retweet heart healthy tips from @FDAWomen

New OWH Publications on Sex Differences and Clinical Trials

The Office of Women’s Health Research and Development Program conducts studies to assess the participation of women in clinical trials in support of FDA product applications and collaborates with FDA centers and external partners to understand the impact of sex differences on response to therapy. In support of these efforts, FDA staff authored two recent publications:

Eshera, N., Itana, H, Zhang, L., Soon, G.,  Fadiran E.O Demographics of Clinical Trials Participants in Pivotal Clinical Trials for New Molecular Entity Drugs and Biologics Approved by FDA from 2010 to 2012. American Journal of Therapeutics, 0, 1-21. 2015. [Epub ahead of print] Eshera et al. provided an update on the demographics of clinical trial participants and on the conduct of sex analyses for New Molecular Entity drugs and biologics approved by FDA between 2010 and 2012 in terms of sex, age and race, and notably found that the inclusion of women was generally comparable to their prevalence in the disease population.

 

Fadiran, E.O., Zhang, L. (2015) Effects of Sex Differences in the Pharmacokinetics of Drugs and Their Impact on the Safety of Medicines in Women. M. Harrison-Woolrych (e.d) Medicines in Women.  (pp. 41-68) This book chapter provides a comprehensive understanding of sex differences in drug pharmacokinetics and of the resulting impacts on drug safety for women.

 

Breast Cancer Public Meeting

On April 2, 2015, FDA will be conducting a public meeting on Breast Cancer Patient-Focused Drug Development. FDA is interested in obtaining patient input on the impact of breast cancer on daily life and patients’ views on currently available therapies to treat the condition. Registration will close on March 23, 2015. View Meeting Announcement and Registration Submit Public Comments

Extras

FDA Commentary on Medscape Highlights Pregnancy Labeling

Medscape posted an interview with FDA experts Melissa S. Tassinari and Jeanine Best, on how the new pregnancy and lactation labeling will help providers make more informed decisions about treatments for pregnant and breastfeeding patients. The interview is a part of a series of commentaries from FDA experts that are designed to improve communication between FDA and clinicians.

FDA on Medscape

Pregnancy and Lactation Labeling Rule

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Consumer Article on Overactive Bladder Treatments

People with overactive bladder have a bladder muscle that squeezes too often or squeezes without warning. Download and share the new consumer update on FDA-approved treatments that can help control overactive bladder symptoms.

FDA Consumer Update: Need Relief from Overactive Bladder Symptoms?

FDA Meetings

Public Conference: The Importance of Getting It Right – How to Measure and Interpret Drug-Induced Liver Injury Information and Make Correct Diagnoses

March 18-19, 2015

College Park Marriott Hotel and Conference Center, Hyattsville, 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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