News: GDUFA II implementation gets revised draft guidance by the FDA

The Generic Drug User Free Program (GDUFA II) received a revised 2017 draft guidance by the US Food and Drug Administration (FDA). The major objective explained in the draft guidance concerns the working of the new fee structures and the assessment of various types of fees.

GDUFA II program clarifies that the facilities manufacturing both APIs and Finished Dosage Forms (FDF) will only include the FDF fees. The program further clarifies the eliminating prior approval supplement fees and adding GDUFA program fees.