Communicating Abbreviated New Drug Application Review Status Updates with Industry

Communicating Abbreviated New Drug Application Review Status Updates with Industry

FDA publishes new MAPP, Communicating Abbreviated New Drug Application Review Status Updates with Industry (5200.12)

Today, October 6, 2017, the FDA published a new Manual of Policies and Procedures (MAPP 5200.12), “Communicating Abbreviated New Drug Application Review Status Updates with Industry.”

This MAPP clarifies the general principles and procedures for communication of abbreviated new drug application (ANDA) review status updates with the authorized representative for an ANDA applicant, as committed to in the Generic Drug User Fee Amendments of 2012 (GDUFA I) and 2017 (GDUFA II). Under GDUFA II, FDA agreed to provide timely ANDA review status updates for all pending ANDAs in response to an authorized representative’s request. This communication facilitates the applicant’s planning and helps ensure public access to affordable, quality generic medicines at the earliest legally available date. 

This new MAPP reflects FDA’s commitments under GDUFA II. Consistent with the GDUFA II commitment letter, this MAPP also eliminates any distinctions between pre- and post-GDUFA I Year 3 submissions.  This MAPP will supersede MAPP 5200.3, Communications with Industry with respect to pre-GDUFA Year Three Abbreviated New Drug Applications.