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  5. Exhibit 2-1 Long Description
  1. Prescription Drug User Fee Amendments

Exhibit 2-1 Long Description

The CMA pilot 1 and Fast-Track/Rolling Review programs are very similar except for timing of agreement and schedule for reviewing the reviewable units (RUs). For the CMA Pilot 1, the eligibility discussion takes place at the end of phase 2 meeting, whereas, with the Fast-Track program the eligibility discussion is held later at the Pre-NDA/BLA meeting. Under the CMA Pilot 1 program the agency commits to review each RUs in 6 months and provide a letter, whereas in the Fast-Track program early review is only when resources are available and not a commitment.

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