The business impact of the Refusal-To-File (RTF) letter is always negative and frequently significant. Research indicates that receiving an RTF letter will not only delay the review process by an average of 17 months, but also decrease stock value.1

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

  • Ancillary benefits to taking a more proactive approach

1. Shin et al., Trends in Refusal to File (RTF) actions from FDA and impact on drug development, Rutgers, The State University of New Jersey, Ernest Mario School of Pharmacy Merck & Co, Inc, https://pharmafellows.rutgers.edu/wp-content/uploads/2019/02/2019-trends-in-refusal-to-file.pdf