US FDA, EMEA look to harmonise postmarketing surveillance

被引：0

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来源：

Reactions Weekly | 2007年 / 1152卷 / 1期

关键词：

Public Health; European Commission; Risk Management; Regulatory Agency; Information Sharing;

D O I：

10.2165/00128415-200711520-00003

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摘要：

引用

页码：2 / 2

共 50 条

[41] GUIDELINES ON POSTMARKETING SURVEILLANCE
WELLS, F
BRITISH MEDICAL JOURNAL, 1988, 296 (6619): : 399 - 400
[42] POSTMARKETING SURVEILLANCE OF IUDS
KESSEL, E
CHI, IC
FELDBLUM, P
CONTRACEPTIVE DELIVERY SYSTEMS, 1983, 4 (01) : 15 - 26
[43] Harmonization: can EMEA & FDA reconcile their differences
Aledort, L. M.
HAEMOPHILIA, 2012, 18 : 8 - 8
[44] An Evaluation of Postmarketing Reports with an Outcome of Death in the US FDA Adverse Event Reporting System
Marwitz, Kathryn
Jones, S. Christopher
Kortepeter, Cindy M.
Dal Pan, Gerald J.
Munoz, Monica A.
DRUG SAFETY, 2020, 43 (05) : 457 - 465
[45] EMEA approves OGS drug rejected by FDA
Mitchell, P
NATURE BIOTECHNOLOGY, 2002, 20 (09) : 858 - 859
[46] EMEA approves OGS drug rejected by FDA
Peter Mitchell
Nature Biotechnology, 2002, 20 : 858 - 859
[47] FDA Increases Focus on Postmarketing Studies
Goozner, Merrill
JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2010, 102 (17) : 1302 - U17
[48] CLINICAL PHARMACOLOGY POSTMARKETING STUDIES: A US FDA EVALUATION OF KNOWLEDGE GAPS AND TRANSLATION INTO LABELING.
Ridge, S.
Guinn, D.
Fletcher, E. Pfuma
Zineh, I.
Madabushi, R.
Ramamoorthy, A.
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2022, 111 : S66 - S67
[49] Drug review and postmarketing surveillance programs are sound, but systems approach to risk management is needed, says FDA
不详
AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY, 1999, 56 (13) : 1294 - +
[50] RECORD LINKAGE FOR POSTMARKETING SURVEILLANCE
FAICH, GA
CLINICAL PHARMACOLOGY & THERAPEUTICS, 1989, 46 (04) : 479 - 480

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