The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

被引：7

作者：

Elahi, Merina ^{[1
]}

Eshera, Noha ^{[1
]}

Bambata, Nkosazana ^{[1
]}

Barr, Helen ^{[2
]}

Lyn-Cook, Beverly ^{[3
]}

Beitz, Julie ^{[4
]}

Rios, Maria ^{[5
]}

Taylor, Deborah R. ^{[5
]}

Lightfoote, Marilyn ^{[2
]}

Hanafi, Nada ^{[2
]}

DeJager, Lowri ^{[6
]}

Wiesenfeld, Paddy ^{[6
]}

Scott, Pamela E. ^{[1
]}

Fadiran, Emmanuel O. ^{[1
]}

Henderson, Marsha B. ^{[1
]}

机构：

[1] US FDA, Off Womens Hlth, WO Bldg 32,Room 2312,10903 New Hampshire Ave, Silver Spring, MD 20993 USA

[2] US FDA, Ctr Devices & Radiol Hlth, Silver Spring, MD 20993 USA

[3] US FDA, Natl Ctr Toxicol Res, Jefferson, AR 72079 USA

[4] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

[5] US FDA, Ctr Biol Evaluat & Res, Silver Spring, MD 20993 USA

[6] US FDA, Ctr Food Safety & Appl Nutr, Silver Spring, MD 20993 USA

来源：

JOURNAL OF WOMENS HEALTH | 2016年 / 25卷 / 03期

关键词：

CARDIAC RESYNCHRONIZATION THERAPY; MOLECULAR ENTITY DRUGS; PHASE CLINICAL-TRIALS; RAT UTERINE GROWTH; PREDICT DISPOSITION; SEX-DIFFERENCES; BREAST-CANCER; PREGNANT-WOMEN; TUMOR SIZE; PBPK MODEL;

D O I：

10.1089/jwh.2015.5671

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for similar to 20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products.

引用

页码：222 / 234

页数：13

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