Cross-Comparison of Cancer Drug Approvals at Three International Regulatory Agencies
Author(s) -
Nardin Samuel,
Subodh Verma
Publication year - 2016
Publication title -
current oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.053
H-Index - 51
eISSN - 1718-7729
pISSN - 1198-0052
DOI - 10.3747/co.23.2803
Subject(s) - medicine , government (linguistics) , drug , cancer drugs , agency (philosophy) , family medicine , drug approval , approved drug , food and drug administration , public health , international agency , regulatory agency , cancer , pharmacology , public administration , political science , pathology , philosophy , linguistics , epistemology
The primary objective of the present study was to examine the drug approval process and the time to approval (tta) for cancer drugs by 3 major international regulatory bodies-Health Canada, the U.S. Food and Drug Administration (fda), and the European Medicines Agency (ema)-and to explore differences in the drug approval processes that might contribute to any disparities.
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