Evaluation of the Adjustment for Changes in Review Activities Applied to the Prescription Drug User Fee Act (PDUFA) IV Workload Adjuster for FY 2009:

By United States Food and Drug Administration and U.S. Food and Drug Administration

The Prescription Drug User Fee Act (PDUFA) authorizes the Food and Drug Administration (FDA) to collect user fees for reviewing and processing applications for the approval of certain human drug and biological products. There are generally four types of applications reviewed: New Drug Applications/Biologics License Applications (NDAs/BLAs); Investigational New Drug Applications (INDs); Efficacy Supplements; and Manufacturing Supplements.1 More information on the Prescription Drug User Fee Act can be found at the following website: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm.

• Format: Paperback
• Language: English
• ISBN: 1502918358
• ISBN13: 9781502918352
• Release Date: October 2014
• Publisher: Createspace Independent Publishing Platform
• Length: 38 Pages
• Weight: 0.25 lbs.
• Dimensions: 0.1" x 8.5" x 11.0"