Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA)
Conclusion and Summary
Question 2/5
Match the GDUFA fee type to its definition.
A.
Backlog Fee
A
B
C
D
One-time fee the first time that an ANDA or PAS references that DMF on or after October 1, 2012
B.
DMF Fee
A
B
C
D
Annual fees that apply to any facility that manufacture both generic FDFs and APIs
C.
New ANDA and PAS Filing Fee
A
B
C
D
One-time application fee for pending ANDAs that were submitted to FDA prior to October 1, 2012
D.
Facility Fee
A
B
C
D
Fee for new applications submitted on or after October 1, 2012, incurred at the time of submission
USER INSTRUCTIONS:
Match the correct answers.
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