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  5. Exhibit 4-12 long description
  1. Prescription Drug User Fee Amendments

Exhibit 4-12 long description

Product K's Clinical section was submitted 12 months before the complete submission was received, a request for information (RFI) was sent to the sponsor within a month and the review of that section was completed 2.5 months after the complete submission. The P/T section was submitted 11.5 months early, an RFI sent10 month later and the review completed .5 months before the complete submission. The CMC submission started the PDUFA clock, an RFI was sent 2 months later, and the CMC review completed 1 month later. The application was approved 4.5 month after the PDUFA clock started. Early review of the Clinical section provided opportunity to submit missing data in time for the first cycle. Product L's CMC section was submitted 3 months before the complete submission, an RFI sent within a month, and the review completed 5.5 months after the complete submission. The P/T section was submitted .5 months early, a RFI sent within 2 months and the review completed 3.5 months after the complete submission was received. Submission of the clinical section started the clock, an RFI was sent at 3 months and the review completed within 6 months. Early CMC feedback allowed sponsor time to address lengthy manufacturing issues. The CMC and P/T sections for Product M were submitted 4 months early. A CMC information request was sent 2 months later and the review completed 1.5 months after complete submission. An RFI was sent for P/T .5 months after receipt of the complete submission. Receipt of the clinical section triggered the PDUFA clock, an RFI was sent at 2.5 months and the application approved at 6 months. The sponsor was able to address all chemistry issues early; received review results seven months seven months before action date.