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  5. Exhibit 4-13 long description
  1. FDA User Fee Programs

Exhibit 4-13 long description

Exhibit 4-13 long description

For Product N, CMC, Clinical and P/T submissions were received 18 months before the complete submission, and additional Clinical and P/T submissions received 3 months prior. There were no requests for information (RFI) received and the application had an approvable action at 10 months. For Product O, the P/T submission was received 8 months prior to complete submission, the CMC submission 7 months prior and the Clinical submission triggered the PDUFA clock. Information requests for Clinical, CMC and P/T were sent out 2 months after complete submission and the application received an approval at 6months. For Product P, the P/T section was submitted 12 months early, the CMC 4 months early and the Clinical section completed the submission. Information requests were sent 2 months after complete submission. The P/T review was completed right after complete submission, the CMC at 2 months and the Clinical at 8.5 months. The application received an approval at 9 months. For product Q, the CMC and Clinical sections were submitted 1 month early and the P/T section started the PDUFA clock. Information requests were sent 1 month after submission and the reviews completed between 3 and 4 months after complete submission and an approval action taken at 4 months. For Product R, the P/T section was submitted 3.5 months early, the CMC section 2.5 months early and the Clinical section triggered the PDUFA clock. There was a clinical information request at 1.5 months and the application received an approvable at 6 months.