FDA revises ANDA prioritization MAPP

On Thursday, the US Food and Drug Administration took action to encourage generic drug development and increase generic drug access by publishing a revision to  MAPP 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements (the “Prioritization MAPP”). This MAPP describes how the review of original abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements are prioritized for review.

As the FDA implemented the Prioritization MAPP under the first two years of the second iteration of the Generic Drug User Fee Amendments ( GDUFA II), it determined that roughly one half of all ANDA submissions received were designated as priority applications. This level of inclusion strained the agency’s limited resources and did not support the agency’s goal of prioritizing review of applications for drug products with the greatest potential impact on the public health. We are revising the MAPP to better meet this critical goal and have posted a  pre-recorded webinar describing these revisions.

In an effort to protect the public health, efficiently allocate limited agency resources, and ensure fairness to applicants, the FDA has refined the MAPP’s prioritization factors and requirements.