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ANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements

GDUFA III includes several enhancements to the abbreviated new drug application (ANDA) assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality, and affordable generics. The terms of the GDUFA III commitment letter provide for enhancements to the ANDA assessment program and goal dates, and industry engagement with FDA regarding information requests and discipline review letters, imminent actions, major deficiencies and delays, assessment classification changes, and teleconferences and meetings.

This page explains important elements in the GDUFA III commitment letter regarding ANDA assessments and goal dates. When available, links to guidances, manuals of policy and procedures (MAPPs) and other resources, such as explanatory presentations, are contained within the sections below. 

On this page:

Goal Dates

This section describes the process for how goal dates will be calculated. This also includes new procedures in the GDUFA III commitment letter for the processing and tracking of applications submitted with facilities that are not ready for inspection.

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Information Requests (IRs) and Discipline Review Letters (DRLs)

FDA is enhancing communications related to IRs and DRLs, including information about filing IRs and potential impacts on assessment goal dates. The GDUFA III commitment letter also includes a new change to the IR response timeframe and specific commitments related to IRs and DRLs for labeling.

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Imminent Actions

The GDUFA III commitment letter uses the term “imminent actions” (formerly “imminent approvals”) and outlines new potential impacts on missed goal dates.

Communicating with Applicants Regarding Deficiencies and Actions

FDA is enhancing communications related to ANDA status, such as major deficiencies, goal date delays, and assessment status updates.

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Assessment Classification Changes

FDA is enhancing the process for changing ANDA, ANDA amendments, prior approval supplement (PAS) or PAS amendment assessment classifications from standard to priority. FDA will also provide recommendations on the process for requesting reclassification of facility-based major complete response letter amendments to minor amendments.

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ANDA Meeting Program

Under GDUFA III, FDA offers new teleconferences and meetings and is enhancing existing meetings available to applicants, including PSG teleconferences, post-submission PSG meetings, mid-cycle review meetings (MCRMs), enhanced mid-cycle review meetings (EMCRMs), post-complete response letter (CRL) teleconferences, and post-CRL scientific meetings.

Note: Information about teleconferences and meetings that are offered to prospective applicants before an ANDA submission, including PSG teleconferences and pre-submission PSG meetings, product development meetings, and pre-submission meetings, can be found on the Pre-ANDA Program Enhancements page.

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