Table 1.

Drugs approved through Notice of Compliance with conditions vs. those approved through a priority and standard review

	Approval based on
	NOC/c*	Priority review	Standard review
Total number NAS†	27	86	265
Number (%) with serious safety warning and/or withdrawn from market for safety reason	11 (40.7)	24 (27.9)	50 (18.9)
Number withdrawn from market with prior safety warning	0	1	6
Number withdrawn from market without prior safety warning	2	0	6
Median time (interquartile range) from application for NOC§ or NOC/c to approval (days)	332 (274, 480)	235 (212, 487)¶	398 (349, 618)**
Median time (interquartile range) from NOC or NOC/c to first serious safety warning or withdrawal from market (days)	1614 (858, 1704)	944 (536, 1429)††	1159 (637, 1583)‡‡

^*NOC/c = Notice of compliance with conditions.

^†NAS = New active substance.

^§NOC = Notice of compliance. ¶Compared with NOC/c, Mann−Whitney, P = 0.0757.

^**Compared with NOC/c, Mann−Whitney, P = 0.0124.

^††Compared with NOC/c, Mann−Whitney, P = 0.1265.

^‡‡Compared with NOC/c, Mann−Whitney, P = 0.2486.