Overview
Receipt of a CRL slows approval, causing increased costs and lost sales, and may prompt withdrawal. The FDA Amendments Act (FDAAA) provided the FDA with new powers in relation to drug safety, including the authority to impose postmarketing requirements (PMRs) and Risk
Evaluation and Mitigation Strategies (REMS) on drug manufacturers, which took effect on March 25, 2008. The FDAAA has increased the costs of drug development due to a rise in post-approval spending: the average number of PMRs issued per drug was four in 2011 compared to two in 2008. Complex REMS, which are issued relatively infrequently, require a significant investment from the applicant compared to REMS that only require medication guides and/or communication plans, and the impact on drug sales is almost certainly negative.
Receipt of a CRL slows approval, causing increased costs and lost sales, and may prompt withdrawal. The FDA Amendments Act (FDAAA) provided the FDA with new powers in relation to drug safety, including the authority to impose postmarketing requirements (PMRs) and Risk
Evaluation and Mitigation Strategies (REMS) on drug manufacturers, which took effect on March 25, 2008. The FDAAA has increased the costs of drug development due to a rise in post-approval spending: the average number of PMRs issued per drug was four in 2011 compared to two in 2008. Complex REMS, which are issued relatively infrequently, require a significant investment from the applicant compared to REMS that only require medication guides and/or communication plans, and the impact on drug sales is almost certainly negative.
Table of Contents
EXECUTIVE SUMMARY
REGULATIONS AND PROCEDURES OF RELEVANCE TO COMPLETE RESPONSE LETTERS
COMPLETE RESPONSE LETTERS AND IMPACT ON APPROVAL
TAKE-HOME MESSAGES TO AVOID COMPLETE RESPONSE LETTERS
APPENDIX
List of Figures
List of Tables