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  5. Exhibit 4-3 long description
  1. Prescription Drug User Fee Amendments

Exhibit 4-3 long description

The percentage of Pilot 1 products with amendments requiring goal extensions was 80% (n=10). The number of products in the Fast-Track cohort with amendments requiring goal extensions was 7 out of 8 products or 88%. In FY 2002-FY2004 the percentage of priority applications with amendments requiring goal extension was 85% or 22 out of 26 products