Understanding the RTF Letter

The business impact of the refusal-to-file (RTF) letter is significant. Research indicates receiving an RTF letter can delay the review process by an average of 17 months and possibly lead to a decrease in stock value. Read and learn how to reduce the likelihood of receiving an RTF letter. Download today for valuable, practical guidance on:

• The RTF processes
• Critical elements to be included for a Food & Drug Administration (FDA) review process
• The business impact associated with receiving an RTF letter
• Ancillary benefits associated with a proactive approach

Download the white paper