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
- Information Requests (IRs) and Discipline Review Letters (DRLs)
- Imminent Actions
- Communicating with Applicants Regarding Deficiencies and Actions
- Assessment Classification Changes
- ANDA Meeting Program
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.
Related Resources:
- Guidance for industry: ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions (December 2022) – For additional information, FDA has prepared a pre-recorded presentation on this revised draft guidance.
- Guidance for industry: Facility Readiness: Goal Date Decisions Under GDUFA Draft Guidance (October 2022) –For additional information, FDA has prepared a pre-recorded presentation on this draft guidance.
- Presentation: GDUFA III Goal Date Illustrations – This video recording covers when original application goal dates are extended, remain unchanged, and even when the goal date may be shortened.
- GDUFA III Goal Date Illustrations (PDF - 581 KB)
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.
Related Resources:
- Guidance for industry: Information Requests and Discipline Review Letters under GDUFA (October 2022)
- MAPP: Issuance of Information Requests and/or Discipline Review Letters for ANDAs (October 2022)
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.
Related Resources:
- Guidance for industry: Cover Letter Attachments for Controlled Correspondences and ANDA Submissions (June 2023)
- Guidance for industry: Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (December 2022)
- MAPP: Communicating ANDA Review Status Updates with Industry (October 2022)
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.
Related Resources:
- Guidance for industry: ANDA Submissions – Prior Approval Supplements Under GDUFA (October 2022)
- MAPP: Prioritization of the Review of Original ANDAs, Amendments, and Supplements (October 2022)
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.
Related Resources:
- Guidance for industry: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (February 2023)
- Guidance for industry: Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Revised Final Guidance (October 2022)
- Guidance for industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA (October 2022)
- Infographic: GDUFA III – Summary of Teleconferences and Meetings (PDF - 117 KB)
- Presentation: GDUFA III Mid-Cycle Review Meetings and Enhanced Mid-Cycle Review Meetings