FDA revised MAPP: Good ANDA Assessment Practices

On Friday, the US Food and Drug Administration (FDA) announced a revised Manual of Policies and Procedures (MAPP 5241.3), “ Good ANDA Assessment Practices.”

This outlines abbreviated new drug application (ANDA) assessment practices for the FDA Office of Generic Drugs (OGD) and Office of Pharmaceutical Quality (OPQ) to increase their operational efficiency and effectiveness, with a goal of decreasing the number of review cycles needed to approve ANDAs that meet the requirements for approval.

Under the Generic Drug User Fee Amendments of 2012 (GDUFA I), the FDA implemented a restructuring of the ANDA assessment program. As part of this restructuring, the FDA adopted performance goals for the review of ANDAs; overhauled the generic drug program’s business processes; developed and implemented an integrated ANDA review information platform; reorganized OGD; established OPQ to, among other things, integrate the ANDA quality assessment; and hired and trained more than 1,000 employees.