Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017." This guidance concerns FDA's implementation of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI) and certain changes in policies and procedures surrounding its application.