Major and Minor Amendments Under GDUFA II – Read Me Loud and Clear

The reauthorization of the Generic Drug User Fee Act GDUFA, which takes effect on October 1, 2017 and commences GDUFA II, has many significant changes relative to goal dates for ANDAs, amendments to ANDAs, and amendments to prior approval supplements.  The system for classifying the goal dates has been simplified from a tiered system under GDUFA I to a standard and priority review system under the new GDUFA iteration.

The FDA draft guidance, ANDA Submissions — Amendments to Abbreviated New Drug Applications Under GDUFA, (here) explains how those goal dates will be assigned.  It also provides examples of how the FDA will establish GDUFA goal dates based on various scenarios.  In addition, the appendix to the guidance gives descriptions of the major and minor classifications the FDA will apply to such designations.

The FDA also describes how it will treat amendments to ANDAs and PASs pending on October 1, 2017 in relation to assignment of permanent goal dates when an ANDA or PAS might have been subject to a tentative action date (TAD).

As a regulatory professional, it is incumbent upon you to study this guidance carefully so you may provide accurate information to your management relative to the timing of ANDA amendment reviews under the various scenarios identified in the guidance document.