The FDA has announced a new prioritization pilot program that will review abbreviated new drug applications (ANDAs) to provide greater support for generics manufactured and tested in the U.S.
The goal of the ANDA prioritization pilot is to increase domestic investment in drug manufacturing and R&D as well as to strengthen the pharmaceutical supply chain. It will achieve this by offering priority review for applicants who conduct any required bioequivalence testing in the United States and whose products are made in the U.S. using exclusively domestic sources for APIs.
Currently, more than half of the drugs distributed in the U.S. are manufactured abroad and many APIs come from outside the U.S. Plus, studies like bioequivalence testing for generics are often carried out in other countries. The new program should strengthen research and development infrastructure by incentivizing more companies to invest in generic manufacturing and testing in the U.S.
Applicants can request this 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 and referencing this pilot program as the basis for prioritization.