For Industry

Prescription Drug User Fee Act (PDUFA)

The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 and renewed in 1997 (PDUFA II), 2002 (PDUFA III), 2007 (PDUFA IV), and 2012 (PDUFA V). It authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

Notice: Effective Monday February 9, 2015, the Prescription Drug User Fee Staff is moving to the new address listed below. Phone numbers remain the same.
  1. For US Mail:
    Prescription Drug User Fee Staff
    Food and Drug Administration
    10001 New Hampshire Avenue, Room 3179
    Silver Spring, MD 20993-0002
  2. For Courier Delivery:
    Prescription Drug User Fee Staff
    Food and Drug Administration
    10001 New Hampshire Avenue, Room 3179
    Silver Spring, MD 20903

News

  • The FY 2016 annual PDUFA invoices were mailed, faxed, and emailed on Monday, August 17, 2015. Payment is due on October 1, 2015. If you do not receive your copy by August 26, 2015, please contact CDER-PDUFA staff at 301-796-7900.
  • The FY 2016 Dear Colleague Letter was mailed, faxed, and emailed on Tuesday, May 5, 2015.  Responses are due by June 10, 2015. If you do not receive your copy, please contact CDER-PDUFA staff at 301-796-7900.
  • The FY 2016 user fee rates have been published: Prescription Drug User Fee Rates for Fiscal Year 2016 (posted 8/3/2015)
Application w/Clinical $2,374,200
Application w/o Clinical $1,187,100
Supplement w/Clinical $1,187,100
Product $114,450
Establishment $585,200

User Fees and Forms

This site provides information on various user fee-related issues.  If you have questions about user fees, you can contact the Prescription Drug User Fee Staff at 301-796-7900.  Mailing address and other contact information.

 

Page Last Updated: 08/20/2015
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