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  5. Exhibit 4-19 long description
  1. Prescription Drug User Fee Amendments

Exhibit 4-19 long description

The distribution within the 17 review divisions of the Fast-Track versus Pilot 1 products is as follows. The following divisions had Pilot 1 products: Cardiovascular and renal had 1 product, Gastroenterology had 1 product, Anti-infectives and Ophthalmology had 6 products, Drug Oncology had 14 products, Medical Imaging and Hematology had 1 product, Biological Oncology had 2 products and Therapeutic Biologics had 2 products. The divisions that had Fast-Track products that were not Pilot 1 are 2 products in Neurology, 1 product in Pulmonary and Allergy, and 6 products in Anti-Virals.

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