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OWH News
January 2013
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Message from the Director
At the onset of 2013, OWH reflected on the tremendous progress that has been made in women’s health - from increases in the participation of women in clinical trials to the successes of the Agency’s Mammography Quality Standards Program. Over the years, OWH has been a catalyst for change and has worked with the support of our partners to promote research and educational programs that respond to the evolving regulatory and public health challenges affecting women. In 2013, we will continue to transform our scientific and communications initiatives. Se our update for vital women’s health information from across FDA including drug alerts, public meetings, publications, and other announcements.
Marsha Henderson, MRCP
Assistant Commissioner for Women’s Health
New Graphic on Safe Medication Use
OWH has released a new infographic that highlights tips on safe medication use and interesting facts about medication use in America. The graphic provides simple steps that people can take to promote the safe and proper use of prescription and over-the-counter medications. The graphic has a specific focus on women, but is also intended for anyone who takes care of medicines for the whole family.
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New Report on Women and Minorities in Clinical Trials
OWH and the Society for Women’s Health Research have released a report on best practices for the recruitment, retention, and analysis of women and minorities in clinical research. This report is the result of the Dialogues on Diversifying Clinical Trials Conference in September 2012 that featured the FDA Office of Minority Health and over 200 representatives from government, industry, patient advocacy groups, and the scientific community.
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FDA Requiring Lower Recommended Dose for Certain Sleep Drugs
FDA on January 10 announced it is requiring the manufacturers of widely used sleep drugs that contain the active ingredient zolpidem to lower current recommended doses. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving. Women appear to be more susceptible to this risk because they eliminate zolpidem from their bodies more slowly than men. Drugs that contain zolpidem include Ambien, Ambien CR, Edluar and Zolpimist, as well as generic versions of Ambien and Ambien CR.
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New IUD Approved
On January 9, FDA approved Skyla - a hormone-releasing system placed in the uterus by a healthcare provider to prevent pregnancy for up to 3 years. Skyla is a small, flexible plastic T-shaped system that slowly releases a progestin hormone called levonorgestrel that is often used in birth control pills. Skyla can be used whether or not you have had a child.
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Be Healthy and Financially Fit in 2013
Resolve to be healthier and more financially organized in 2013 with a free packet of publications from OWH, the Federal Deposit Insurance Corporation (FDIC) and the Consumer Financial Protection Board. The packet features tips on antibiotics and over-the-counter medications; ways to recognize and protect your family from health scams; and strategies for building your savings, understanding your credit report, and getting better service from your bank.
Due to overwhelming demand, print copies of the packet are no longer available. However, you can still view or download the publications.
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Watch Videos from the 2012 FDA Clinical Investigator Training
Videos are now available from the November 2012 FDA Clinical Investigator Training Course for medical professionals (experts who sign FDA Form 1572 before participating in an investigation). The videos discuss clinical trial design, clinical pharmacology, and special cardiac safety issues such as QT prolongation.
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Update Your Women’s Health Email Preferences
OWH has updated the email preference options available to subscribers. These options allow you to choose the emails that you are interested in receiving, on topics such as reproductive health, breast cancer, college health, minority health, and more. Health professionals: make sure to sign up for our email list just for you to be updated on FDA safety alerts, research, actions, and product information, and program updates relevant to women's health professionals.
Reproductive Health Drugs Advisory Committee Meeting
March 4, 2013 – 8:00 a.m. – 5:00 p.m.
FDA White Oak Campus
During the morning session, the committee will discuss new drug application (NDA) 022506, gabapentin 600 milligram (mg) tablets, submitted by Depomed, Inc., for the proposed indication of treatment of moderate to severe vasomotor symptoms due to menopause.
During the afternoon session, the committee will discuss NDA 204516, paroxetine mesylate 7.5 mg capsules, submitted by Noven Therapeutics, LLC, for the proposed indication of treatment of moderate to severe vasomotor symptoms associated with menopause.
View the full meeting announcement and materials.
Conferences
Check out an OWH exhibit booth or presentation at one of these conferences to learn more about OWH programs, research, and free educational resources.
OWH Exhibits
- Delta Sigma Theta, Jan 10-12 – Washington, DC
- American Pharmacists Association, Mar 1-4 – Los Angeles, CA
- Aging in America, Mar 12-16 – Chicago, IL
- American Association of Colleges of Nursing, Mar 17 – Washington, DC
- Women’s Health Congress 2013, Mar 22-24 – Washington, DC
OWH Presentations
- Cardiovascular Research Technologies (CRT), Feb 23-26 – Washington, DC. Poster: Demographics of Study Participants in Clinical Trials for Cardiovascular Drugs Approved by FDA from 2010 to 2011
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