Evaluation of the Adjustment for Changes in Review Activities Applied to the Prescription Drug User Fee Act (PDUFA) IV Workload Adjuster for FY 2009: Contributor(s): Food and Drug Administration (Author) |
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ISBN: 1502918358 ISBN-13: 9781502918352 Publisher: Createspace Independent Publishing Platform OUR PRICE: $15.19 Product Type: Paperback Published: October 2014 |
Additional Information |
BISAC Categories: - Reference |
Physical Information: 0.08" H x 8.5" W x 11.02" (0.25 lbs) 38 pages |
Descriptions, Reviews, Etc. |
Publisher Description: 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 |