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.

This FDA guidance document provides answers to expected user-fee questions from generic drug industry participants regarding the Generic Drug User Fee Amendments of 2012.

The key questions addressed in this guidance are:

• Who was required to pay a backlog fee?
• How did FDA define pending applications for purposes of paying the backlog fee?
• How much is the backlog fee, how is it assessed, and when is it due?
• If FDA refused, after October 1, 2012, to receive an original ANDA submitted before October 1, 2012, was the application subject to a backlog fee?
• If FDA refuses to receive an application in the backlog, will the backlog fee be refunded?
• If FDA refuses to receive an application in the backlog, will the sponsor be required to pay an application fee upon resubmission in response to the identified issue(s)?
• What is the penalty for failure to pay the backlog fee?
• What is an “affiliate” for this purpose?
• Which DMFs incur fees?
• When is a DMF fee incurred?
• Do holders of DMFs submitted and reviewed by FDA before October 1, 2012, have to pay a DMF fee?
• Do DMF holders incur a fee each time their DMF is referenced?
• How much is the DMF fee?
• When are DMF fees due?
• Do DMF holders need to wait for a new ANDA applicant to request a letter of authorization before the DMF is assessed to be available f or reference?
• What is the penalty for failure to pay the DMF fee?

The FDA guidance has addressed these questions and more to ensure compliance to GDUFA requirements.

Related Training:

Drug Master Files: New Requirements under GDUFA