As outlined in the GDUFA III Commitment Letter, these performance metrics must be reported each fiscal year.
Original and PAS Review
| GDUFA FY Performance | Review Time Goal | Actions Completed | Percent on Time | Potential Range | On-Time Imminent Action | Imminent Action Potential Range |
|---|---|---|---|---|---|---|
| Original ANDA Review | ||||||
| Standard Original ANDA Submissions | 10 months | 29 of 400 | 97% | 7% to 99% | 100% | 7% to 100% |
| Priority Original ANDA Submissions (if applicant meets requirements of a PFC) | 8 months | 5 of 18 | 100% | 28% to 100% | 100% | 28% to 100% |
| Priority Original ANDA Submissions (if applicant does not meet the requirements of a PFC) | 10 months | 5 of 66 | 100% | 8% to 100% | 100% | 8% to 100% |
| Standard and Priority Original Facility not Ready with Reset | 30 months | — | — | — | — | — |
| Amendment Review | ||||||
| Standard Major ANDA Amendments (if PAI is not required) | 8 months | 167 of 513 | 95% | 31% to 98% | 98% | 32% to 99% |
| Standard Major ANDA Amendments (if PAI is required) | 10 months | 2 of 8 | 100% | 25% to 100% | 100% | 25% to 100% |
| Priority Major ANDA Amendments (if PAI is not required) | 6 months | 41 of 88 | 100% | 47% to 100% | 100% | 47% to 100% |
| Priority Major ANDA Amendments (if PAI is required and applicant meets the requirements of a PFC) | 8 months | — | — | — | — | — |
| Priority Major ANDA Amendments (if PAI is required and applicant does not meet the requirements of a PFC) | 10 months | — | — | — | — | — |
| Standard and Priority Minor ANDA Amendments | 3 months | 485 of 746 | 86% | 58% to 91% | 98% | 64% to 99% |
| PAS Review Time Goals | ||||||
| Standard PAS (if PAI is not required) | 6 months | 973 of 1685 | 99% | 57% to 99% | 99% | 58% to 99% |
| Standard PAS (if PAI is required) | 10 months | 6 of 25 | 100% | 24% to 100% | 100% | 24% to 100% |
| Priority PAS (if PAI is not required) | 4 months | 89 of 118 | 96% | 74% to 97% | 99% | 75% to 99% |
| Priority PAS (if PAI is required and applicant meets the requirements of a PFC) | 8 months | 0 of 1 | — | — | — | — |
| Priority PAS (if PAI is required and applicant does not meet the requirements of a PFC) | 10 months | 1 of 3 | 100% | 33% to 100% | 100% | 33% to 100% |
| PAS Amendment Review Time Goals | ||||||
| Standard Major PAS Amendment (if PAI is not required) | 6 months | 51 of 102 | 100% | 50% to 100% | 100% | 50% to 100% |
| Standard Major PAS Amendment (if PAI is required) | 10 months | 0 of 1 | — | — | — | — |
| Priority Major PAS Amendment (if PAI is not required) | 4 months | 8 of 11 | 88% | 64% to 91% | 100% | 73% to 100% |
| Priority Major PAS Amendment (if PAI is required and applicant does not meet the requirements of a PFC) | 10 months | — | — | — | — | — |
| Standard and Priority Minor PAS Amendments | 3 months | 200 of 247 | 98% | 79% to 98% | 99% | 81% to 99% |
FDA Meeting Commitments
| GDUFA FY Performance | Review Time Goal | Actions Completed | Percent on Time | Potential Range |
|---|---|---|---|---|
| Product Development Meetings | ||||
| Grant or deny Product Development Meeting requests | 14 days | 92 of 97 | 100% | 95% to 100% |
| Conduct or provide written response to granted Product Development Meetings | 120 days | 73 of 80 | 100% | 91% to 100% |
| Provide preliminary written comments before each Product Development Meeting unless FDA is providing a written response | 5 days before meeting | 37 of 47 | 100% | 79% to 100% |
| Provide meeting minutes | 30 calendar days following the meeting | 14 of 21 | 100% | 67% to 100% |
| Pre-Submission Meetings | ||||
| Grant or deny Pre-Submission Meeting Requests | 30 days | 7 of 7 | 100% | 100% to 100% |
| Conduct granted Pre-Submission Meetings | 60 days | 2 of 2 | 100% | 100% to 100% |
| Provide preliminary written comments if appropriate to the purpose of the meeting | 5 calendar days before each meeting | 2 of 2 | 100% | 100% to 100% |
| Provide meeting minutes | Within 30 days of the meeting | 2 of 2 | 100% | 100% to 100% |
| PSG Teleconferences and Meetings | ||||
| Conduct granted PSG Teleconferences | 30 days | 3 of 3 | 100% | 100% to 100% |
| Grant or deny a meeting request for a Pre-Submission PSG Meeting | 14 days | — | — | — |
| Conduct granted Pre-Submission PSG Meetings | Within 120 days from receipt of request | — | — | — |
| Grant or deny a meeting request for a Post-Submission PSG Meeting | 14 days | — | — | — |
| Schedule granted Post-Submission PSG Meetings if the applicant has submitted an ANDA | Within 90 calendar days from receipt of request | — | — | — |
| Mid-Cycle Review Meetings | ||||
| Conduct Mid-Cycle Meetings | 30 days | 6 of 6 | 100% | 100% to 100% |
| Conduct Enhanced Mid-Cycle Meeting | 90 days | 6 of 7 | 100% | 85% to 100% |
| Post-CRL Teleconferences | ||||
| Provide a scheduled date for a requested Post-CRL teleconference | 10 days | 65 of 68 | 94% | 90% to 94% |
| Conduct requested Post-CRL teleconferences on the FDA-proposed date | 30 days | 65 of 68 | 97% | 93% to 97% |
| Post-CRL Scientific Meetings | ||||
| Provide a scheduled date for a requested Post-CRL Scientific Meeting | 10 days | 18 of 19 | 100% | 95% to 100% |
| Conduct or provide written response to granted Post CRL Scientific Meeting | 90 days | 11 of 14 | 91% | 72% to 91% |
DMF Review
| GDUFA FY Performance | Count | Granted | Completed |
|---|---|---|---|
| DMF | |||
| Requests for review of a DMF prior to ANDA or PAS submission | 16 | 15 | 12 |
| Priority and non-priority “off-cycle” solicited DMF amendments reviewed | 55 |
Imminent Actions
| GDUFA FY Performance | Count |
|---|---|
| Imminent Actions | |
| Original Approvals that are Imminent Actions | 35 |
| Original TAs that are Imminent Actions | 19 |
Abbreviations (in order of appearance):
PAS: Prior Approval Supplement
ANDA: Abbreviated New Drug Application
PFC: Pre-Submission Facility Correspondence
TA: Tentative Approval
PAI: Pre-Approval Inspection
PSG: Product-Specific Guidance
CRL: Complete Response Letter
DMF: Drug Master File
Previous Fiscal Year Reports
Related Resources
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Content current as of:
12/08/2025
