viernes, 26 de junio de 2015

Summer e-Update: Women's Health Highlights from FDA Office of Women's Health

Office of Women's Health, FDA
June/ July 2015

Message from the Director

Throughout the summer, FDA is busy working to keep you safe. In this update, we highlight some of the Agency’s ongoing efforts to monitor the safety of products used by women including birth control and cosmetics. There are also links to FDA resources on HIV, sun safety, and nutrition. Whether you are on vacation or at the office, I encourage you to look to FDA for the health information that can help both you and your family.

Marsha Henderson
Assistant Commissioner for Women’s Health



medicine picture
Essure is a permanent birth control method for women (female sterilization). FDA takes reports of problems with Essure very seriously. The agency is actively evaluating postmarket experiences with this device. 
Public Meeting
FDA plans to convene a public meeting of the Obstetrics and Gynecology Devices Panel on September 24, 2015 to discuss scientific data regarding Essure’s safety and effectiveness. At this meeting, the FDA invites feedback from presenters, panel members and the public to inform recommendations and next steps about Essure.
New Essure Webpage
FDA is committed to keeping patients and health care providers informed by sharing information as it becomes available. FDA updated its Essure Web Pageto include information for patients and health care providers.

FDA Guidance on Pregnancy, Lactation, and Reproductive Potential Labeling

drawing of pregnant woman's belly
This guidance is intended to help small businesses better understand and comply with the new content and format requirements of the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products.
Read the Guidance (PDF 164KB).

How to Report a Problem with Cosmetics

drawing of laptop computer
Cosmetic products range from lipstick and nail polish to deodorant and hairspray. While many people don’t have any problems after using cosmetics, reactions sometimes occur. FDA wants to know if you’ve had a reaction to a cosmetic product. You can report any reaction related to a cosmetic, from a minor rash or headache to an illness that put you in the hospital. You can even report something that didn’t cause a reaction, but alerted you to a problem with the product, such as a bad smell or other sign of contamination. A consumer, a health care provider, or a salon professional can report a problem. It helps if only one person files a report on each incident

Should You Put Sunscreen on Infants? Not Usually

Babies' skin is less mature compared to adults, and infants have a higher surface-area to body-weight ratio compared to older children and adults. Both these factors mean that an infant's exposure to the chemicals in sunscreens may be much greater, increasing the risk of side effects from the sunscreen. The best protection is to keep your baby in the shade, if possible.

HIV Testing Resources

June 27th is National HIV Testing Day. FDA has resources that you can use at your events to help educate women about HIV testing, prevention, and treatment.

FDA Cuts Trans Fat in Processed Foods

FDA finalized its determination that partially hydrogenated oils (PHOs), the primary dietary source of artificial trans fat in processed foods, are not “generally recognized as safe” or GRAS for use in human food. Food manufacturers will have three years to remove PHOs from products.

FDA Meetings

July 7-8, 2015
FDA White Oak Campus, Silver Spring, MD
The committees will discuss the results of post marketing studies evaluating the misuse and/or abuse of reformulated OXYCONTIN (oxycodone hydrochloride) extended-release tablets, supplemental new drug application.

OWH Conference Calendar

The Office of Women’s Health exhibits and presents at conferences across the country to increase awareness of FDA’s women’s health resources and programs. Check out an OWH exhibit booth or presentation at one of these conferences:
YWCA, June 4-6 – Washington, DC
American Association of Nurse Practitioners, June 9-12 – New Orleans, LA
American Library Association*, June 25-30 – San Francisco, CA
American College of Nurse-Midwives, June 28—National Harbor, MD
Teratology Society, June 27-July 1 – Montreal, Canada
National Association of Hispanic Nurses*, July 7-10 – Anaheim, CA
National Council of La Raza*, July 11-14 – Kansas City, MO
American Association of Colleges of Pharmacy, July 11-15 – National Harbor, MD
National Area Agencies on Aging*, July 11-15 – Philadelphia, PA
Delta Sigma Theta National Public Service Convention, July 23-29 – Houston, TX
National Black Nurses Association*, July 29- August2 – Atlanta, GA

*Come meet the local FDA Public Affairs Staff who support our women’s health field outreach.
FDA Office of Women's Health
10903 New Hampshire Avenue
WO32 - Room 2333
Silver Spring, MD 20993*0002

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