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  5. Exhibit 4-2 long description
  1. Prescription Drug User Fee Amendments

Exhibit 4-2 long description

The percentage of Pilot 1 products approved in a single cycle was 70% (n=7) with 30% (n=3) in multiple cycles. The percentage of products approved in the first cycle that were in the Fast-Track cohort was 50% (n=4) with 50% (n=4) in multiple cycles. The percentage of priority applications approved in the first cycle in FY2002-FY2004 was 62% (n=16) with 38% (n=10) had multiple cycles.