Standard Costs for the Process for the Review of Human Drug Applications asRequired Under the Prescription Drug User Fee Act

摘要

This report contains the results of a study to calculate standard costs for theprocess for the review of human drug applications by the Food and Drug Administration, as defined by the Prescription Drug User Fee Act of 1992. It explains how the standard costs for Fiscal Year 1993 are calculated and lists them. The report summarizes the law and describes its standard cost provisions. It explains and defines the eleven standard cost elements that represent the process for the review of human drugs. The report explains the products, activities and costs that are included and excluded in the standard costs. It also explains the methodology and assumptions used to calculate standard costs.