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. 2016 Aug 29;1(5):399–412. doi: 10.1016/j.jacbts.2016.06.003

Figure 1.

Figure 1

Comparison of Drug Approval Processes in the United States and EU

After clinical trials, FDA drug approvals follow a centralized path, whereas European approval can occur through 4 different paths, depending on the nature of the drug and the preference of the manufacturer. EIND = emergency investigational new drug; EMA = European Medicines Agency; EU = European Union; FDA = Food and Drug Administration; IND = investigational new drug.