For Consumers

FDA Office of Women's Health Update Archive

 

 

The words e-update with blue background

The Office of Women's Health e-Update highlights women's health initiatives, meetings, and regulatory safety information from the U.S. Food and Drug Administration (FDA). The e-Update is disseminated via email to the public.

Current Issue:  November - December 2014

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

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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.

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New Guidance on Vaginal Microbicides for HIV Prevention

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.

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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.

 

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OWH Brochure now available 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.

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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.

 

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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.

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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.

 

Report a vaccine problem:

 

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FDA Meetings

 

Public Workshop: Electronic Cigarettes and Public Health

December 10-11, 2014

FDA White Oak Campus, Silver Spring, MD

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Past OWH e-Update Issues

  

Contact FDA

301-796-9440
Fax:301-847-8604
Food and Drug Administration Office of Women's Health

10903 New Hampshire Avenue

WO32-2333

Silver Spring, MD 20993

Page Last Updated: 11/21/2014
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