New Market Report: Complete Response Letter Trends and Approval Strategies

New Pharmaceuticals market report from Datamonitor: "Complete Response Letter Trends and Approval Strategies"

by Bill Thompson

(WireNews+Co) - Boston, MA - 15 March 2013

A Complete Response Letter (CRL) describes deficiencies in an NDA/BLA submission that prevent the FDA from approving the application in its original form. Where possible, the CRL will make recommendations for corrective action that the applicant should take. Receipt of a CRL slows approval, causing increased costs and lost sales, and may even prompt withdrawal of the application.

Report Scope

- Assess the impact that an advisory committee vote is likely to have on approval and the probability that a Complete Response Letter will be issued.
- Evaluate how long a Complete Response Letter is likely to delay approval.

View Full Report Details (http://www.fastmr.com/prod/546442_complete_response_letter_trends_and_approval.aspx?afid=201) (http://www.fastmr.com/prod/546442_complete_response_letter_trends_and_approval.aspx?afid=201)

Report Hightlights

Deficiencies in NDA/BLA submissions that triggered a Complete Response Letter include failures of Good Manufacturing Practice, insufficient evidence of clinical efficacy or safety, clinical data integrity issues, non-clinical studies, and labeling deficiencies. The most common deficiency was insufficient evidence of efficacy or safety.

Reasons to Get this Report

- How can applicants reduce the risk that the FDA will issue a Complete Response letter?
- How can company press releases relating to Complete Response Letters provide insight into the likely approval delay?

Report Table of Contents:

Table of Contents
Complete Response Letter Trends and Approval Strategies
Carousel catalyst
Overview
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 Respone 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

Fast Market Research (http://www.fastmr.com?afid=201) is an online aggregator and distributor of market research and business information. Representing the world's top research publishers and analysts, we provide quick and easy access to the best competitive intelligence available. Our unbiased, expert staff will help you find the right research to fit your requirements and your budget.  For more information about these or related research reports, please visit our website at http://www.fastmr.com or call us at 1.800.844.8156.