Appendix C: FDA Interview Guide
Assessment of Planned Review Timelines: Root Cause Analysis
Interview Guide for FDA RPMs
1) Did you participate in training on implementation of planned review timelines processes?
2) Why were planned review timelines for labeling and PMR/PMC discussions not included in the filing communication letter? (If applicable)
3) In your case, why were labeling discussions not initiated by the target date specified in the filing communication? (If applicable)
4) What could be improved in the process or tools available that would help to meet the target dates for initiating these discussions with the sponsor?