Priority review
A priority review is given to a New Drug Application or Biologics License Application if the drug treats an unmet medical need. It cuts the review time under the Prescription Drug User Fee Act from 10 months down to 6 months.
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A priority review is given to a New Drug Application or Biologics License Application if the drug treats an unmet medical need. It cuts the review time under the Prescription Drug User Fee Act from 10 months down to 6 months.