GDUFA (Generic Drugs User free Amendment)

GDUFA (Generic Drugs User free Amendment)

The Generic Drug User Fee Amendments of 2012 authorizes FDA to assess and collect user fees for human generic drug applications, certain application supplements, and related manufacturers. Form FDA 3794, also known as the Generic Drug User Fee Cover Sheet or GDUFA Cover Sheet, is designed to collect the minimum necessary information to determine the total applicable user fee required and to help FDA track the user fee payments. Furthermore, FDA’s review of a generic drug submission cannot begin until all relevant user fee obligations have been satisfied.

GDUFA is applicable for following cases

• Abbreviated new drug application (ANDA) or applicable amendment;
• Prior approval supplement (PAS) or applicable amendment;
• Type II active pharmaceutical ingredient (API) drug master file (DMF) that is referenced on or after October 1, 2012, in a generic drug submission to the FDA and for which the DMF fee has not already been paid;
• Generic drug facility which is identified in at least one generic drug submission that is approved to produce a finished dosage form (FDF) of a human generic drug or an API contained in a human generic drug; and
• Backlog ANDA which is pending on October 1, 2012, and that has not received a tentative approval prior to that date.