Message from the Director
As we close out another busy summer, the OWH staff is working hard to advance our many research and outreach projects. I encourage you to read this edition of the eUpdate to learn more about OWH scientific workshops, health education collaborations, and conference exhibits. In addition to these exciting activities, you will also find information on OWH efforts to support other FDA and HHS initiatives.
Marsha Henderson, MRCP
Assistant Commissioner for Women’s Health (Acting)
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OWH partners with the AACP on National College Campaign
OWH is collaborating with the American Association of Colleges of Pharmacy as a part of the ongoing OWH national college campaign. The initiative with AACP will make OWH consumer publications available to 120 schools of pharmacy. The free publications on a range of vital women’s health topics will be used in pharmacy courses, training programs, community outreach, or student health services.
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New Diabetes Collaboration with the USDA
OWH, the USDA National Institute of Food and Agriculture (NIFA), and the Cooperative Extension System (CES) are partnering on a project to promote and support diabetes prevention and control among women and their families across the country. OWH diabetes booklets and other consumer publications will be disseminated through the Cooperative Extension System for use in activities at the state, local, and community levels.
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OWH Sponsors Symposium for FDA Scientists
OWH sponsored a science symposium for FDA researchers and reviewers on September 14th, 2010. The day-long event featured a key note presentation by Marianne J. Legato - Professor at Columbia University College of Physicians & Surgeons and Johns Hopkins Medical School, and founder of the Partnership for Gender-Specific Medicine at Columbia. Dr. Legato’s talk emphasized the importance of a sex-specific approach toward current genomic research. The symposium also showcased scientific sessions and poster presentations by OWH-funded researchers and fostered dialogue on sex differences in pathophysiology, disease outcomes, and response to therapeutic products.
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Registration Open for OWH/DIA Patient Recruitment Conference
OWH and the Drug Information Association are sponsoring a joint conference entitled “Partnerships and Collaborations to Advance Patient Recruitment in Clinical Research” on October 14-15, 2010 at the Hilton Rockville Hotel. The conference will address strategies for recruiting and retaining women and minorities in drug trials.
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New Office of Minority Health at FDA
The Patient Protection and Affordable Care Act called for the creation of an FDA Office of Minority Health (OMH) in the Office of the Commissioner. The newly established FDA OMH will work across the Agency and with the HHS Office of Minority Health and outside partners to support scientific research and sponsor scientific and consumer outreach efforts.
The agency will conduct a national search for a director. In the interim, OWH, as well as other offices within the agency, will continue their on-going minority health activities. Marsha Henderson will serve as Acting OMH Director. Since March 2010, she has served, and will continue to serve, as the Acting Director for the Office of Women’s Health.
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FDA approves ella™ tablets for prescription emergency contraception
On August 13th, FDA approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.
ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Side effects most frequently observed with ella in the clinical trials include: headache, nausea, abdominal pain, pain/discomfort during menstruation (dysmenorrhea), fatigue, and dizziness. The profile of side effects for ella is similar to that of FDA-approved levonorgestrel emergency contraceptives.
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New Consumer Update on Pregnancy Registries
FDA recently released a new consumer update entitled “Registries Help Moms Measure Medication Risks”. The article aims to educate women about studies that collect and maintain data on the effects of medications used by pregnant and nursing women on themselves and their babies. The update also highlights the OWH pregnancy exposure registry website which provides contact information on over 40 registries.
OWH Pregnancy Exposure Registry Website
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Tobacco Regulations Mobile Texting Pilot
Sign up now to have important tips and educational messages about FDA tobacco product regulations delivered directly to your mobile phone. The FDA’s Center for Tobacco Products has launched a six-month text messaging campaign pilot to educate and raise awareness about tobacco product regulations designed to protect kids from the dangers of tobacco use and its negative health impacts.
Learn More about the Pilot Project
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FDA Advisory Committee Meetings
Radiological Devices Panel - Medical Devices Advisory Committee
Date: September 24, 2010
Time: 8 a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C , D
620 Perry Pkwy., Gaithersburg, MD
The committee will discuss, make recommendations, and vote on a premarket approval application for the Selenia C Digital Breast Tomosynthesis System intended for use in the same clinical applications as traditional mammographic systems.
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Cardiovascular and Renal Drugs Advisory Committee
Date: September 20, 2010
Time: 8:00 a.m. to 5:00 p.m.
Location: Hilton Washington DC/Silver Spring - The Ballrooms
8727 Colesville Road, Silver Spring, Maryland
The committee will discuss new drug application (NDA) 22–512, dabigatran etexilate mesylate capsules, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the proposed indication of prevention of stroke in patients with atrial fibrillation (abnormally rapid contractions of the atria, the upper chambers of the heart).
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NIH Office of Research on Women’s Health 20th Anniversary
The National Institutes of Health (NIH) will be celebrating the 20th anniversary of the establishment of the Office of Research on Women’s Health on September 27, 2010. The daylong event, to include a reception, will provide a forum to recognize some of the major contributors to the establishment of ORWH and will celebrate progress in the field of women’s health research. In addition, ORWH will unveil and launch the third scientific agenda for women’s health research for the coming decade, entitled “A Vision for 2020 for Women’s Health Research: Moving into the Future with New Dimensions and Strategies”.
Date: September 27, 2010
Time: 9:00 a.m. – 5:15 p.m.
Location: Natcher Conference Center (NIH Campus in Bethesda, MD)
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Update Extras
OWH staff conduct presentations and workshops at national conferences and meetings to update FDA stakeholders about OWH scientific and outreach activities. Information about OWH presentations is available online.
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Conferences
OWH exhibits at conferences across the country to increase awareness of OWH programs and resources and to increase dissemination of the over 50 OWH fact sheets and brochures available for consumers. Visit the OWH exhibit booth at these upcoming conferences:
Hispanic Association of Colleges and Universities, Sept 18-20 – San Diego, CA
Gay & Lesbian Medical Association, Sept 22-25 – San Diego, CA
AARP, Sept 30 – Oct 2 – Orlando, FL
North American Menopause Society, Oct 6-9 – Chicago, IL
APHA, Nov 7-10 – Denver, CO
National Conference on Health Disparities, Nov 10-13 – Philadelphia, PA
National Congress of American Indians, Nov 14-19 – Albuquerque, NM
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Want more information from the FDA Office of Women’s Health?
Follow OWH on Twitter: FDAWomen - http://twitter.com/fdawomen
Visit the OWH website: www.fda.gov/womens
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Please share this update with your network, members, constituents, and community.
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