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Market Research Report

Trends: Hot Topic Catalyst

Published by Datamonitor Healthcare Product code 973520
Published Content info 48 Pages
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Trends: Hot Topic Catalyst
Published: November 19, 2020 Content info: 48 Pages
Description

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.

Table of Contents
Product Code: DMKC0093126

TABLE OF CONTENTS

CONTENTS

EXECUTIVE SUMMARY

  • Overview of US drug approval regulations and procedures
  • Complete Response Letters and impact on approval
  • Take-home messages to avoid Complete Response Letters

REGULATIONS AND PROCEDURES OF RELEVANCE TO COMPLETE RESPONSE LETTERS

  • The FDA regulatory burden is increasing
  • US drug submissions process
  • References

COMPLETE RESPONSE LETTERS AND IMPACT ON APPROVAL

  • Trends in Complete Response Letters
  • FDA advisory committee meetings and Complete Response Letters
  • References

TAKE-HOME MESSAGES TO AVOID COMPLETE RESPONSE LETTERS

  • Common deficiencies that trigger a Complete Response Letter
  • Case studies
  • Neutroval (tbo-filgrastim)
  • Bydureon (exenatide)
  • Nucynta ER (tapentadol)
  • Lamictal (lamotrigine)
  • Menveo (meningococcal ACWY vaccine)
  • Horizant (gabapentin enacarbil)

APPENDIX

  • About the author
  • Scope
  • Methodology

LIST OF FIGURES

  • Figure 1: Full-time equivalent FDA staff, FY2000-10
  • Figure 2: Number of postmarketing requirements by drug approval year, 2000-11
  • Figure 3: Approvals, Complete Response Letters, and withdrawals as a percentage of total applications, FY2009-12
  • Figure 4: Approval delay (months) for submissions that received a single Complete Response Letter
  • Figure 5: Number and percentage of NME/BLA submissions referred to advisory committee, FY2008-11
  • Figure 6: Comparison of advisory committee votes and approval status
  • Figure 7: Common deficiencies that trigger a Complete Response Letter

LIST OF TABLES

  • Table 1: Number of NDAs/BLAs and FDA workload, FY2009-11
  • Table 2: Number of postmarketing requirements by drug approval year, 2000-11
  • Table 3: Number of drug submissions, Complete Response Letters, resubmissions, and approvals, FY2009-12
  • Table 4: Company comments and action taken after receiving a Complete Response Letter
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