Evaluation of the Adjustment for Changes in Review Activities Applied to the Prescription Drug User Fee Act (PDUFA) IV Workload Adjuster for FY 2009: (Paperback) (ISBN-13: 9781502918352)

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

Author: Food and Drug Administration
ISBN-10: 1502918358
ISBN-13: 9781502918352
Publisher: Createspace Independent Publishing Platform
Language: English
Published: 10/31/2014
Pages: 38
Format: Paperback
Weight: 0.25lbs
Size: 11.02h x 8.50w x 0.08d