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

共 50 条

[1] The food and drug administration office of Women's Health: Impact of science on regulatory policy
Obias-Manno, Dulce
Scott, Pamela E.
Kaczmarczyk, Joseph
Miller, Margaret
Pinnow, Ellen
Lee-Bishop, Lynda
Jones-London, Michelle
Chapman, Kennerly
Kallgren, Deborah
Uhl, Kathleen
JOURNAL OF WOMENS HEALTH, 2007, 16 (06) : 807 - 817
[2] Physiologically Based Pharmacokinetic Modeling in Regulatory Science: An Update From the US Food and Drug Administration's Office of Clinical Pharmacology
Grimstein, Manuela
Yang, Yuching
Zhang, Xinyuan
Grillo, Joseph
Huang, Shiew-Mei
Zineh, Issam
Wang, Yaning
JOURNAL OF PHARMACEUTICAL SCIENCES, 2019, 108 (01) : 21 - 25
[3] US Food and Drug Administration Office of Women's Health: Promoting Therapeutic Optimization in Women
South, Erin M.
Zinn, Rebekah L.
Huang, Caroline J.
Vasisht, Kaveeta P.
JOURNAL OF CLINICAL PHARMACOLOGY, 2020, 60 : S11 - S17
[4] Advances in Regulatory Science at the Food and Drug Administration
Psaty, Bruce M.
Goodman, Steven N.
Breckenridge, Alasdair
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2013, 309 (20): : 2103 - 2104
[5] Regulatory science within US Food and Drug Administration
Patwardhan, Dinesh
ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 2017, 254
[6] Women's Health, Pregnancy, and the US Food and Drug Administration
Gee, Rebekah E.
Wood, Susan F.
Schubert, Kathryn G.
OBSTETRICS AND GYNECOLOGY, 2014, 123 (01): : 161 - 165
[7] The Food and Drug Administration's Regulation of Tobacco The Center for Tobacco Products' Office of Science
Ashley, David L.
Backinger, Cathy L.
AMERICAN JOURNAL OF PREVENTIVE MEDICINE, 2012, 43 (05) : S255 - S263
[8] Bridging the Health Equity Gap: An Update from the US Food and Drug Administration Office of Minority Health and Health Equity
Araojo, Richardae
Lee, Christine
Lolic, Milena
HEALTH EQUITY, 2024, 8 (01) : 235 - 237
[9] CARDIOVASCULAR MEDICAL DEVICES: REGULATORY SCIENCE RESEARCH OVERVIEW IN THE OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL) AT THE FOOD AND DRUG ADMINISTRATION (FDA)
Aycock, Kenneth
Blinova, Ksenia
Casciola, Maura
Craven, Brent
Di Prima, Matthew
D'Souza, Gavin
Duraiswamy, Nandini
Farahmand, Masoud
Hariharan, Prasanna
Herbertson, Luke
Jamiolkowski, Megan
Lu, Qijin
Malinauskas, Richard
Patel, Mehulkumar
Rinaldi, Jean
Sivan, Shiril
Vesnovsky, Oleg
Weaver, Jason
PROCEEDINGS OF THE 2021 DESIGN OF MEDICAL DEVICES CONFERENCE (DMD2021), 2021,
[10] Tobacco Regulatory Science: Research to Inform Regulatory Action at the Food and Drug Administration's Center for Tobacco Products
Ashley, David L.
Backinger, Cathy L.
van Bemmel, Dana M.
Neveleff, Deborah J.
NICOTINE & TOBACCO RESEARCH, 2014, 16 (08) : 1045 - 1049

← 1 2 3 4 5 →