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

Exhibit 4-4 long description

The total number of issues identified prior to first action in Pilot 1 products (n=6) was 50 versus 55 issues in the comparison cohort (n=8). The issues identified prior to first action by category were, CMC: 20 issues in Pilot 1 versus 23 in the comparison cohort; Efficacy: 15 issues in pilot 1 versus 17 in the comparison cohort; and Safety: 15 issues in Pilot 1 versus 16 in the comparison cohort.