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Regulatory factor impact
| Regulatory factor | Effect (years) | 95% CI |
|---|---|---|
| Accelerated approval | −3.0 | (−4.5, −1.5) |
| Breakthrough designation | −1.3 | (−2.6, 0.0) |
| Orphan designation | +1.5 | (+0.4, +2.6) |
| >1 Review cycle | +1.8 | (+0.4, +3.2) |
Effect size of US FDA regulatory factors on shortening (−) or increasing (+) clinical development times.
See Supplementary Box 1 for details of the dataset and analysis.
