The Food and Drug Administration Office of Women's Health: impact of science on regulatory policy.
In 1994, the Food and Drug Administration Office of Women's Health (FDA-OWH) was created to provide leadership and policy direction for the Agency regarding issues of women's health. Within its first year, the FDA-OWH established a science program for women's health research, promoting the developme...
| Publicado en: | Journal of Women's Health (15409996) Vol. 16; no. 6; pp. 807 - 818 |
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| Autores principales: | , , , , , , , , , |
| Formato: | research Journal Article |
| Publicado: |
Mary Ann Liebert, Inc.
Jul/Aug2007
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=105834771&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105834771 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 15409996 Q13 jtl: Journal of Women's Health (15409996) issn: 15409996 maglogo: N pubinfo: dt: Jul/Aug2007 vid: 16 iid: 6 pid: 1365 pub: Mary Ann Liebert, Inc. place: New Rochelle, New York artinfo: ui: 105834771 26086480 2009647285 10.1089/jwh.2006.0135 NLM17678451 105834771 ppf: 807 ppct: 11 formats: tig: atl: The Food and Drug Administration Office of Women's Health: impact of science on regulatory policy. aug: au: Obias-Manno D Scott PE Kaczmarczyk J Miller M Pinnow E Lee-Bishop L Jones-London M Chapman K Kallgren D Uhl K sug: subj: Health Policy Legislation and Jurisprudence Research Legislation and Jurisprudence United States Food and Drug Administration Economics Women's Health Adverse Drug Event Legislation and Jurisprudence Budgets Female Health Policy Economics Health Policy Trends Leadership Policy Making Research Economics United States Food and Drug Administration Administration United States Human Female ab: In 1994, the Food and Drug Administration Office of Women's Health (FDA-OWH) was created to provide leadership and policy direction for the Agency regarding issues of women's health. Within its first year, the FDA-OWH established a science program for women's health research, promoting the development of sound policy and regulation. In a little over a decade, the program has provided approximately 14 million dollars to fund more than 100 women's health research studies covering a broad range of health topics affecting women across their lifespan. Some studies, such as those elucidating drug effects on QT prolongation in women and drug-dietary supplement interaction, have had significant influence on regulatory decisions. Other studies have provided sound scientific data on sex and gender differences supporting FDA guidelines to protect women's health. This paper describes the science program at the FDA-OWH, providing examples of how funded research impacts regulatory policy. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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