MaPP Clarifies How OGD will Communicate Deficiencies Found in Initial Filing Review

Don’t need to get out your GPS because MaPP 5220.3 will help you understand how OGD plans to navigate the filing review to communicate major and minor deficiencies to the applicant in an information request (IR).  If the minor deficiencies can be resolved within a 7-day period, then your ANDA has the chance to be received on the original submission date.  In addition, OGD outlines the process for conveying major deficiencies where the data might be in the ANDA, but they just can’t locate it in the ANDA.  Those types of major deficiencies (those where the info is there, but just can’t be found) will also be able to be rectified in the 7-day period.

Remember that a MaPP is an internal FDA document that explains how the Agency goes about its work. It provides transparency of the process to the industry.  A full copy of the MaPP can be accessed here.