issues....1 2 3
not for altar boys Fda........For a Priority Review, the RPM prepares one of the following three communication types: 1. If there are filing issues but they are not ready to send to applicant by day-60, send the Priority Review Determination letter by day-60 then send the Filing Issues Identified Letter by day-74. 2. If there are filing issues and they are ready to send to the applicant by day-60, send the Filing Issues Identified letter by day-60. 3. If there are no filing issues, send the No Filing Issues Identified letter to the applicant by day-60.