Not sure if CTAP operates under the same conditions as CBER "Fast Track" but as per below table from FDA some can be overdue. Interesting to note per the stats the majority overdue were approved. One would think any denials would be pretty quick, while the longer the submission continues the more back and forth additional evidence may be required for assessment.CBER "Fast Track" Designation Request Performance Report
All Requests Received
(March 1, 1998 through March 31, 2022)
Number Submitted Goal Within Goal Overdue Granted Denied Pending Total % Granted Denied Pending Total % 672* 60 days 445 186 18 649 97 17 3 3 23 3 *Does not include three requests received by OTRR and pending on October 1, 2003. Final actions on those requests are counted in CDER reports.
