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U.S. Department of Health and Human Services

Drugs

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Learn about the Generic Drug User Fee act for fee, uhhh, free

 

On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law. GDUFA is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. The law requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities. 
 
This webinar will outline:
  • the agreement
  • the fee collection process and the types of fees
You will learn about the backlog fee -- a one-time application fee for generic abbreviated new drug applications that are pending as of October 1; the Type II Drug Master File fee – which covers the manufacture of an active pharmaceutical ingredient or drug substance.  Bring your wallet! Not really – this is a free webinar.
 
(More information about GDUFA fees and the new review process can be obtained during CDER’s webinar, “Generic Drug User Fee Amendment (GDUFA) – User Fees and More” on Monday, October 22, 2012 at 11 a.m. (ET). The following link provides complete information on the registration process:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm323860.htm
 
Useful link:
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm316790.htm