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.
The following sections explain important elements in the GDUFA III commitment letter regarding ANDA assessments and goal dates. Where available, links to guidances, manuals of policy and procedures (MAPPs) and other resources are contained within the sections below. Note: FDA will add information and presentations to this page on an ongoing basis as more guidances and MAPPs become available.
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.
- Facility Readiness: Goal Date Decisions Under GDUFA Draft Guidance – This new draft guidance provides information to applicants on how FDA intends to assign a goal date based on a facility’s readiness for inspection as certified on Form FDA 356h submitted as part of an original ANDA under the Federal Food, Drug, and Cosmetic Act. For additional information, please view a pre-recorded presentation on this draft guidance.
- GDUFA III Goal Date Illustrations – This presentation covers when original application goal dates are extended, remain unchanged, and even when the goal date may be shortened.
Information Requests (IRs) and Discipline Review Letters (DRLs)
This section describes communication enhancements to IRs and DRLs, including information about filing IRs and potential impacts on assessment goal dates. It also describes the new change to the IR response timeframe in the GDUFA III commitment letter. Finally, this section provides helpful information around the specific commitments related to IRs and DRLs for labeling.
This section describes the change in terminology from imminent approvals to imminent actions and the potential impacts on missed goal dates in the GDUFA III commitment letter.
Communicating with Applicants Regarding Deficiencies and Actions
This section describes communication enhancements related to ANDA status, such as major deficiencies, goal date delays, and assessment status updates.
Assessment Classification Changes
This section describes the enhancements to the process for changing ANDA, ANDA amendments, prior approval supplement (PAS) or PAS amendment assessment classifications from standard to priority. This section also describes the process for industry to request reclassification of facility-based major complete response letter amendments to minor amendments.
ANDA Meeting Program
This section describes new teleconferences and meetings and enhancements or changes to existing meetings available to applicants under the terms of the GDUFA III commitment letter. This includes a new teleconference option for applicants that have commenced an in vivo bioequivalence study and want to obtain agency feedback on the potential impact of a new/revised product-specific guidances (PSGs) on its development program. This section also includes the process for requesting and conducting mid-cycle review meetings (MCRMs), including the difference between a standard MCRM and enhanced MCRM in the GDUFA III commitment letter. Further, it includes information about post-complete response letter (CRL) teleconferences and post-CRL scientific meetings that industry may request with FDA.
Note: Information about teleconferences and meetings that are offered to prospective applicants before an ANDA submission can be found on the Pre-ANDA Program Enhancements page.
Infographic GDUFA III – Summary of T-Cons and Meetings (PDF - 117 KB)