FDA released Revision 1 to its November 12, 2015 Manual of Policy and Procedures (MAPP) 5200.7 which contains “minor clarifications and formatting”, and added Attachment 2 – Work Guide for Prior Approval Supplements: Requirements for a Filing Review.
Just a reminder that a MAPP is a document that provides a transparent view into how the FDA deals with an issue internally. It is not a guidance to industry, but rather a window into what happens at the FDA once a submission is made, or another internal process.
In this document, FDA explains its process for deciding when an amendment to a pending ANDA or a supplement to an approved application is made for certain changes in strength, concentration, formulation, fill size of a parenteral product, switch from Rx to OTC of a product, change in container closure of a parenteral product, or reintroduction of a strength that has never been marketed or not marketed for a number of years.
Division of Filing Review (DFR) may need to get involved regarding patent or exclusivity issues and or to determine if the proposed change is one that is permitted by regulation and to perform a standard filing review to determine if the amendment or supplement is substantially complete for review purposes or if it should be refused-to-file (RTF). The revised MAPP can be viewed here.
