iii Risk Evaluation and Mitigation Strategies for US Drug Development, Second Edition
Table of Contents
1. The Limits of Risk and the Concept of the REMS................................................. 1
2. Pharmaceutical Risk Management Plans Before REMS. ......................................11
3. When is a REMS needed?. ..................................................................................17
4. Medication Guides: Components of REMS from 2008–2011............................. 25
5. Components of a REMS: Communication Plans and Implementation Systems.... 33
6. Components of a REMS: Elements to Assure Safe Use (ETASU). ........................35
7. Components of a REMS: REMS Assessment. ......................................................43
8. Anticipating, Preparing and Filing a REMS......................................................... 49
9. Modifying a REMS Being Released From a REMS............................................. 59
10. REMS for Entire Drug Classes. ...........................................................................65
11. REMS and the Opioid Crisis............................................................................... 71
12. REMS for Drugs for Use in Infants, Children and Adolescents. ..........................79
13. Effect of a REMS on the Speed of Review and Approval of New Drugs............... 83
14. The Impact of REMS on Generic Drug Approvals and Drug Competition......... 87
15. Effects of the REMS Program on the Healthcare System and Pharmaceutical
Competition........................................................................................................ 95
16. The Evolving REMS Process................................................................................ 99
17. Guidance Documents and Databases on REMS. ...............................................103
Appendices
Appendix 1............................................................................................................... 109
Appendix 2............................................................................................................... 113
Appendix 3............................................................................................................... 119
Appendix 4............................................................................................................... 123
Index........................................................................................................................ 145
About the Author..................................................................................................... 157
Table of Contents
1. The Limits of Risk and the Concept of the REMS................................................. 1
2. Pharmaceutical Risk Management Plans Before REMS. ......................................11
3. When is a REMS needed?. ..................................................................................17
4. Medication Guides: Components of REMS from 2008–2011............................. 25
5. Components of a REMS: Communication Plans and Implementation Systems.... 33
6. Components of a REMS: Elements to Assure Safe Use (ETASU). ........................35
7. Components of a REMS: REMS Assessment. ......................................................43
8. Anticipating, Preparing and Filing a REMS......................................................... 49
9. Modifying a REMS Being Released From a REMS............................................. 59
10. REMS for Entire Drug Classes. ...........................................................................65
11. REMS and the Opioid Crisis............................................................................... 71
12. REMS for Drugs for Use in Infants, Children and Adolescents. ..........................79
13. Effect of a REMS on the Speed of Review and Approval of New Drugs............... 83
14. The Impact of REMS on Generic Drug Approvals and Drug Competition......... 87
15. Effects of the REMS Program on the Healthcare System and Pharmaceutical
Competition........................................................................................................ 95
16. The Evolving REMS Process................................................................................ 99
17. Guidance Documents and Databases on REMS. ...............................................103
Appendices
Appendix 1............................................................................................................... 109
Appendix 2............................................................................................................... 113
Appendix 3............................................................................................................... 119
Appendix 4............................................................................................................... 123
Index........................................................................................................................ 145
About the Author..................................................................................................... 157