General Information Regulatory

US FDA updated MAPP for ANDA consolidation process

The US Food and Drug Administration (FDA) has made certain changes in the Manual of Policies and Procedures (MAPP) for reviewing the requests to consolidate previously approved generic drug applications.

This revised MAPP will replace the original version of October 2015 document and has been entitles as “Consolidation of ANDAs by the Office of Generic Drugs”. This revised MAPP gives detailed description for the sponsors who are willing to consolidate different ANDAs for same drug of different strengths into a single “parent” ANDA. The parent ANDA is generally finalized on the basis of which drug product strength was utilized for the bioequivalence studies.

After the approval of the consolidation and when it is being effected, sponsors will have to submit just single previous approval supplement or single change being effected submission under the parent ANDA for a desired change to the drug product strength. Then all the post-marketing reports can be consented through the previous parent ANDA.

In this revision the workflow for the review process of ANDA consolidation has been updated. FDA has made an announcement for this update as this position “coordinates requests for consolidation, determines whether any of the ANDAs identified in the request for consolidation have associated open or outstanding issues, makes the consolidation determination, and ensures ANDAs are properly consolidated”. Also in this update the roles of OGD regulatory project managers and document room staff has been mentioned.

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