FDA Revises Policy on Prioritizing Generic Drug Applications

In a revised Manual of Policy and Procedures (MAPP), the FDA outlined a new policy on prioritizing reviews of ANDAs.

The FDA will no longer prioritize submissions from first filers over the course of ANDA review, the MAPP said.

The agency will also prioritize submissions for which final approval depends on the expiration of a patent or NDA exclusivity.

In addition, ANDA supplements will be prioritized if they are related to a drug shortage or public health emergency, or would present significant difficulties for the applicant if delayed.

Office of Generic Drugs Director Sally Choe said the agency will focus on submissions that are “most likely to have a meaningful impact on generic drug access,” noting that roughly half of all ANDA submissions were designated priority submissions under the previous policy.