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January 2013
www.fda.gov/womens
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At the onset of 2013, OWH
reflects 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. See our update
for vital women's health information from across FDA, including drug alerts, public meetings,
publications, and other announcements
Marsha Henderson, M.C.R.P.
Assistant Commissioner for Women's Health
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FDA Women's Health Highlights
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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.
View the Graphic
and Share with your Networks. |
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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.
View
the Report
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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.
Read the Drug Safety
Communication |
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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.
Check the label to read more about all of the risks and benefits of
using Skyla.
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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.
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.
View
the Videos.
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.
Take
a moment to update your preferences.
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Committee Meetings, Exhibits and Presentations
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March 4, 2013 - 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
full meeting announcement and materials
View the full
Advisory Committee Calendar.
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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 View past OWH presentations.
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