Spending the PDUFA funds

WASHINGTON - FDA has released a detailed road map for implementation of its commitments under the second round of the Prescription Drug User Fee Act (PDUFA II), which runs from 1998 to 2002.

PDUFA II requires FDA to review some types of applications more rapidly and adds a number of new resource-intensive commitments, including a transition to electronic receipt and review of applications by 2002 and new goals for meetings and dispute resolution...