PDUFA VII’s Big Commitments: ‘Goal Inflation’ Accelerates

14 Sep 2021

• By Michael McCaughan

Latest iteration of the Prescription Drug User Fee Act agreement negotiated by US FDA and the pharmaceutical industry continues the trend to ever larger sets of goals and commitments as part of the reauthorization process.

The seventh iteration of the Prescription Drug User Fee Act agreement between the US Food & Drug Administration and the pharmaceutical industry is, in a very literal sense, a big deal.

The goal letter, released by FDA for public comment in mid-August, is quite literally big, running 71 pages divided...