Table 2.

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.