FDA Complete Response Letter Analysis

PDF Edition - FDA Complete Response Letter Analysis: How 51 Companies Turned Failure to Success

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FDA Complete Response Letter Analysis
How 51 Companies Turned Failure to Success

A complete response letter (CRL) from the FDA delays a product’s entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them.

Imagine how much you could save if you could anticipate the FDA’s concerns and address them before the agency issues the complete response letter? Now you can.

Researcher Theresa Allio, Ph.D., analyzed CRLs issued for 51 products approved by the FDA since 2009 and discovered striking underlying patterns:

  • Forty-seven percent of CRLs name deficiencies in CMC requirements. Imagine knowing which areas the FDA faults, then resolving these problems in advance.
  • The same percentage of CRLs list deficiencies related to product labeling. Here, too, knowledge is power — to resolve deficiencies before a CRL arrives.
  • Forty-five percent of CRLs include comments related to specific clinical deficiencies, many of which could be addressed during the drug development process to avoid unnecessary delays in an application’s review.

And this is just the tip of the iceberg. To discover the patterns CRLs share, Dr. Allio analyzed dozens of these documents. Her work makes crystal clear exactly which deficiencies could trigger CRLs in your company — and how to head them off.

Reading FDA Complete Response Letter Analysis can be an eye-opening experience. Do you know:

  • The most common reasons CRLs are issued and how to prevent them?
  • Key turning points in working with the FDA that sponsors must not ignore?
  • Impact of various types of CRLs on time-to-market?
  • Strategies for clearing FDA CRL objections without needless delays?

Understanding what triggers a CRL, and what to do if you get one, can save millions of dollars and months of delay — years, even — getting products to market. Here’s how to gain that understanding — in about one hour of reading time.

 

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Table of Contents

  • Deficiencies Cited in CRLs
  • Lessons Learned
  • CRLs and Time to Market

View the entire TOC

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Theresa Allio Ph.D. has 10 years’ experience in drug development, including service in academia, industry and the FDA. She started her career at Vertex Pharmaceuticals, serving a key regulatory role on the Incivek and Kalydeco development teams. While at the FDA, she served as a nonclinical reviewer and as support staff for the Pediatric Advisory Committee.
Here’s a suggested list of potential readers:
  • Drug developers
  • Pharmaceutical researchers
  • Market researchers
  • Regulatory affairs staff
  • Drug company executives
  • Clinical trial operators
  • In-house/outside counsel
  • Executive staff
  • Board of Directors members

Get Multi-user Access With The Electronic Books Library.
Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the Electronic Books Library – a personalized collection of FDAnews publications that is fully searchable. Contact customer service for a quote or more information.

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