Appendix B: Updated FY09 Planned Review Timelines Data
In Appendix C of the FY 2010 Performance Report to Congress and the President on the Prescription Drug User Fee Act, FDA provided updated data from FY09. These data were updated based on two factors:
• Applications that had previously been classified as “pending” because they had not reached the communicated target date by the end of FY09 were evaluated
• FDA considered the requirement to include the target date in the filing communication letter fulfilled if the date was included in a filing review letter.
The updated FY09 data are shown below.