Sample characteristics
N (%) | |
Companies | 42 |
Size | |
Large | 17 (40) |
Non-large | 25 (60) |
Headquarter location | |
US | 26 (62) |
Non-US | 16 (38) |
Products | 62 |
Type | |
Drugs | 40 (65) |
Biologics | 22 (35) |
FDA approval year | |
2016 | 16 (26) |
2017 | 46 (74) |
Trials | 1017 |
Trials conducted in patients | 391 (38) |
FDAAA applicable trials | 236 (23) |
Median number of trials supporting each product approval (IQR) | 13 (8–21) |
Median number of trials in patients for approved indication supporting each product approval (IQR) | 5 (3–8) |
Median number of FDAAA applicable trials supporting each product approval (IQR) | 3 (2–5) |
FDA, Food and Drug Administration; FDAAA, FDA Amendments Act.