Understanding the RTF Letter: Practical guidance on what the FDA is looking for, and how to avoid receiving one

By YourEncore
Published: November 2019

The business impact of the Refusal-To-File letter is always negative and frequently significant. However, there are many activities a company can undertake to reduce the likelihood of receiving an RTF letter. Download this white paper for practical guidance on:

  • The RTF process and what the FDA is looking for
  • The business impact associated with receiving an RTF letter
  • Activities organizations can undertake to reduce their risk
  • And ancillary benefits to taking a more proactive approach
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Since 2003, YourEncore has been delivering premier strategic and technical advisory services and solutions to the Life Sciences industry. Our subject matter experts are experienced industry practitioners – alumni from some of the most respected companies in the world – offering their extensive hands-on experience in solving the same challenges our clients face today, to help them outthink, outpace, and outperform the competition. Our mission is to enable a world of experience to make a difference in the world. For more information, visit www.yourencore.com.