FDA Updates Its Policies for Reviewing ANDAs and Good ANDA Assessment Practices

The agency announced a revised Manual of Policies and Procedures for ANDA assessment. Here's what's you need to know.

Last month, FDA revised its manual of policies and procedures (MAPP) for conducting a filing review of an abbreviated new drug application (ANDA) by the Office of Generic Drugs’ (OGD) Division of Filing Review (DFR).

It’s the first revision since 2017 and went into effect on October 3.

Background

The FDA assesses each ANDA to ensure it is complete and contains all required data before it is received.

A received ANDA is deemed "substantially complete," meaning it is ready for a substantive review as per section 505(j)(2)(A) of the FD&C Act and lacks any deficiencies outlined in 21 CFR 314.101(d) and (e).

Post-receipt, the ANDA undergoes further review. If additional information is required, an Information Request (IR) is sent to the applicant, or a refuse-to-receive notification may be issued if necessary.

This MAPP outlines OPQ’s ANDA assessment practices to increase their operational efficiency and effectiveness, with the goal of decreasing the number of review cycles.

The revised filing checklist

The revisions to the policy include an updated ANDA Filing Checklist, which the FDA says will help DFR Reviewers assess the information and data in ANDA submissions.

The new checklist includes modules for DFR reviewers to use to identify required and recommended content on each application.

Here’s a brief breakdown of each module:

• Module 1 reviews administrative information, including all signatures, patent certifications and exclusivity certifications, and the product comparison demonstrating “sameness” or differences related to the reference drug.