Get the latest FDA News on Clinical Trials, Vaginal Microbicides, and more

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Fri, 21 Nov 2014 11:27:15 -0600

Title:     Get the latest FDA News on Clinical Trials, Vaginal Microbicides, and more

            November/ December 2014
www.fda.gov/womens

            Message from the Director
As we closeout another busy and successful year, I
just wanted to highlight some of the great work FDA has done in 2014 to protect
and promote the health of women. In addition to our ongoing support of women’s
health research, FDA released final guidance to industry on the evaluation
of sex differences in medical device studies and the new final guidance
highlighted in this update on the development of vaginal
microbicides for HIV prevention. This year the Agency also worked to draft
the Action Plan to Enhance the Collection and Availability of Demographic
Subgroup Data and just today unveiled a Drug Trials Snapshots webpage that will
provide a new level of transparency about demographic data in clinical studies
of new FDA-approved drugs and biologics. Lastly, we have expanded our efforts
to provide FDA health information to women with the update of our Medication
Safety Tips for Women webpage and the release on new online tools for
pregnant women and women with disabilities. This update is just one method we
use to get the word out about these new FDA policies and public health
initiatives. I encourage you to not only read this update but continue to look
to us in 2015 for future women’s health news from the FDA.

Marsha
Henderson

Assistant Commissioner for Women’s Health

           FDA Women's Health Highlights

           FDA Posts Drug Trials Snapshots
FDA has launched a new webpage that will provide a
clearinghouse for easy to understand and readily available information about
the age, race, and sex of clinical trial participants in clinical studies of
FDA-approved drugs and biologics.  The
information will be organized in a new document that FDA is calling Drug Trials
Snapshots. FDA is seeking feedback from the public
on the content, format and overall usability of the first six Snapshots. 

See the Drug Trials Snapshots here: www.fda.gov/drugtrialssnapshot
New Guidance on Vaginal Microbicides 

FDA
published final guidance for Industry on the development of vaginal
microbicides for the prevention of human immunodeficiency virus (HIV)
infection. The final guidance addresses the FDA’s current thinking regarding
the overall development program and clinical trial designs to support the
development of vaginal microbicide drug products.
Read
the Guidance Document

           OWH Expands Pregnancy Promotion

Since December 2013, OWH has
conducted a national promotion to provide health professionals and other community-based
service providers with materials they can use to educate women about medication
use during pregnancy. OWH recently expanded the promotion to include FDA brochures
on Food Safety for Pregnant Women and co-branded pregnancy materials from our
partners MotherToBaby and text4baby.

Order Materials 

OWH Brochure in Braille

The OWH Use Medicines Wisely brochure is now
available in Braille. The brochure provides four tips to help women avoid
common medication mistakes. 
Order Braille copies on the OWH publication page on
USA.gov.

                              Extras

           FDA approves extended-release pain killer with abuse-deterrent properties

FDA
approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid
analgesic to treat pain severe enough to require daily, around-the-clock,
long-term opioid treatment and for which alternative treatment options are
inadequate. Hysingla ER has properties that are expected to reduce, but not
totally prevent, abuse of the drug when chewed and then taken orally, or
crushed and snorted or injected.

Information
on Hysingla ER 

FDA Diabetes Resources

FDA has
free resources to help women with diabetes manage their condition. Learn more
about FDA-approved medicines and devices and get general tips for maintaining a
healthy diet.

Women
     and Diabetes 
Food
     Safety for People with Diabetes
Safety
Information for Diabetes Medicines and Devices

Flu Vaccines

A lot
of the illness and death caused by the flu can be prevented by a yearly flu
vaccine. Get the facts about flu vaccines. 

FDA
     Information on Flu Vaccines
Flu.gov

 Report
a vaccine problem:

Vaccine
     Adverse Event Reporting System (VAERS) is a Federal program
     used to report injuries or illnesses that occur after a vaccine is given. 
National Vaccine
     Injury Compensation Program provides compensation to people found to
     be injured by certain vaccines. 

            FDA Meetings

Public
Workshop: Electronic Cigarettes and
Public Health

December
10-11, 2014 

FDA
White Oak Campus, Silver Spring, 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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