Draft PDUFA VI Implementation Plan (FY 2018-2022)
MARCH 30, 2018
U.S. FOOD AND DRUG ADMINISTRATION
As part of the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) under Title 1 of the FDA Reauthorization Act of 2017, FDA committed to furthering the Agency’s implementation of structured benefit-risk assessment into the human drug review program.1,2 In fulfillment of one of these commitments, FDA is publishing an update to the 2013 implementation plan titled “Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making.”