Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments

• By: Staff Editor
• Date: November 27, 2016
• Source: http://www.fda.gov/

Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments

The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. GDUFA requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.

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