Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition iv
Figures
Figure I-1. Evolution of Risk Management Plans for Drugs with a
High-Risk Profile.....................................................................................vi
Figure 1-1. Evolution of Formal Risk Management Plans for Drugs With a
High-Risk Profile*. ..................................................................................3
Figure 1-2. Basis for FDA’s Process of Determining Risk of a Drug............................ 6
Figure 1-3. FDAAA-Mandated Advisory Commitee Meeting. ...................................7
Figure 4-1. History of Medication Guides for Approved Products............................ 26
Tables
Table 3-1. NDAs and BLAs With REMS Approved January 2017–May 2018........ 18
Table 3-2. Products Approved Before 25 March 2008 Deemed to Have a REMS. ...21
Table 6-1. ETASUs Approved Per Year................................................................... 37
Table 8-1. REMS Components. .............................................................................49
Table 10-1. Shared System REMS. ...........................................................................66
Table 12-1. Products With Pediatric Indications Approved by FDA,
March 2008–September 2009................................................................ 80
Table 16-1. Risk Minimization Tool Kit. ................................................................101