Snapshot

The ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing pathway has been developed by the of United States.

This pathway can be used where generic drugs and biosimilars that are manufactured and tested entirely in the United States of America. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Target time assessment is Applicants can request priority review by following the procedures outlined in FDA’s Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements (“Prioritization MAPP”) and referencing this pilot program as the basis for prioritization. Applicants should provide information with their priority review request to demonstrate that their ANDA qualifies for the pilot (i.e., (1) that either the pivotal bioequivalence testing was conducted in the U.S. or that the ANDA qualifies for a waiver of bioequivalence testing, (2) that the finished dosage form manufacturer is located in the U.S., and (3) that the API supplier is located in the U.S.)..