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Initial decisions on cohort marketing applications by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
| Initial EMA outcome, N = 107 | ||||
|---|---|---|---|---|
| Approved (98) | Not approved (3) | Withdrawn (6) | ||
|
Initial FDA outcome, N = 107 |
Approved (91) | 90 | 1 | 0 |
| Not approved (14) | 8 | 2 | 4 | |
| Withdrawn (2) | 0 | 0 | 2 | |
Shaded cells indicate concordant outcomes.
