Generic Drugs Program 2024 Fiscal Year Web Posting
As outlined in the GDUFA III Commitment Letter, these performance metrics must be reported each fiscal year.
Original and PAS Review
| 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 | 50 of 456 | 96% | 11% to 100% | 100% | 11% to 100% |
| Priority Original ANDA Submissions (if applicant meets requirements of a PFC) | 8 months | 5 of 24 | 100% | 21% to 100% | 100% | 21% to 100% |
| Priority Original ANDA Submissions (if applicant does not meet the requirements of a PFC) | 10 months | 14 of 115 | 93% | 11% to 99% | 100% | 12% 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 | 171 of 580 | 94% | 29% to 98% | 99% | 29% to 100% |
| Standard Major ANDA Amendments (if PAI is required) | 10 months | 1 of 8 | 100% | 13% to 100% | 100% | 13% to 100% |
| Priority Major ANDA Amendments (if PAI is not required) | 6 months | 44 of 102 | 93% | 44% to 97% | 98% | 44% to 99% |
| Priority Major ANDA Amendments (if PAI is required and applicant meets the requirements of a PFC) | 8 months | 0 of 1 | N/A | 0% to 100% | N/A | 0% to 100% |
| Priority Major ANDA Amendments (if PAI is required and applicant does not meet the requirements of a PFC) | 10 months | 0 of 3 | N/A | 0% to 100% | N/A | 0% to 100% |
| Standard and Priority Minor ANDA Amendments | 3 months | 508 of 808 | 87% | 57% to 91% | 96% | 62% to 98% |
| PAS Review Time Goals | ||||||
| Standard PAS (if PAI is not required) | 6 months | 1020 of 1563 | 99% | 65% to 99% | 99% | 65% to 100% |
| Standard PAS (if PAI is required) | 10 months | 20 of 51 | 100% | 39% to 100% | 100% | 39% to 100% |
| Priority PAS (if PAI is not required) | 4 months | 68 of 87 | 99% | 78% to 99% | 99% | 78% to 99% |
| Priority PAS (if PAI is required and applicant meets the requirements of a PFC) | 8 months | -- | -- | -- | -- | -- |
| Priority PAS (if PAI is required and applicant does not meet the requirements of a PFC) | 10 months | 0 of 4 | 0% | 0% to 100% | 0% | 0% to 100 |
| PAS Amendment Review Time Goals | ||||||
| Standard Major PAS Amendment (if PAI is not required) | 6 months | 56 of 88 | 95% | 61% to 97% | 96% | 61% to 98% |
| Standard Major PAS Amendment (if PAI is required) | 10 months | 1 of 1 | 100% | 100% to 100% | 100% | 100% to 100% |
| Priority Major PAS Amendment (if PAI is not required) | 4 months | 8 of 11 | 100% | 73% to 100% | 100% | 73% to 100% |
| Priority Major PAS Amendment (if PAI is required and applicant does not meet the requirements of a PFC) | 10 months | 1 of 2 | 100% | 50% to 100% | 100% | 50% to 100% |
| Standard and Priority Minor PAS Amendments | 3 months | 187 of 237 | 96% | 77% to 97% | 98% | 78% to 98% |
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 | 85 of 85 | 99% | 99% to 99% |
| Conduct or provide written response to granted Product Development Meetings | 120 days | 58 of 69 | 100% | 84% to 100% |
| Provide preliminary written comments before each Product Development Meeting unless FDA is providing a written response | 5 days before meeting | 29 of 42 | 100% | 69% to 100% |
| Provide meeting minutes | 30 days following the meeting | 15 of 20 | 100% | 75% to 100% |
| Pre-Submission Meetings | ||||
| Grant or deny Pre-Submission Meeting Requests | 30 days | 3 of 3 | 100% | 100% to 100% |
| Conduct granted Pre-Submission Meetings | 60 days | -- | -- | -- |
| Provide preliminary written comments if appropriate to the purpose of the meeting | 5 days before each meeting | -- | -- | -- |
| Provide meeting minutes | Within 30 days of the meeting | -- | -- | -- |
| PSG Teleconferences and Meetings | ||||
| Conduct granted PSG Teleconferences | 30 days | 1 of 1 | 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 days from receipt of request | -- | -- | -- |
| Mid-Cycle Review Meetings | ||||
| Conduct Mid-Cycle Meetings | 30 days | 4 of 4 | 100% | 100% to 100% |
| Conduct Enhanced Mid-Cycle Meeting | 90 days | 4 of 4 | 100% | 100% to 100% |
| Post-CRL Teleconferences | ||||
| Provide a scheduled date for a requested Post-CRL teleconference | 10 days | 70 of 70 | 89% | 89% to 89% |
| Conduct requested Post-CRL teleconferences on the FDA-proposed date | 30 days | 68 of 70 | 96% | 91% to 96% |
| Post-CRL Scientific Meetings | ||||
| Provide a scheduled date for a requested Post-CRL Scientific Meeting | 10 days | 14 of 14 | 93% | 93% to 93% |
| Conduct or provide written response to granted Post CRL Scientific Meeting | 90 days | 6 of 10 | 100% | 60% to 100% |
DMF Review
| GDUFA FY Performance | Count | Granted | Completed |
|---|---|---|---|
| DMF | |||
| Requests for review of a DMF prior to ANDA or PAS submission | 9 | 8 | 3 |
| Priority and non-priority "off-cycle" solicited DMF amendments reviewed | 87 | -- | -- |
Imminent Actions
| GDUFA FY Performance | Count |
|---|---|
| Imminent Actions | |
| Original Approvals that are Imminent Actions | 40 |
| Original TAs that are Imminent Actions | 13 |
NOTE: Numbers reflect current data at the time of posting and may change based on refreshed counts in our tracking systems, including application status updates.
These numbers are not intended for Congressional reporting purposes.
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
- Monthly and Quarterly Activities Report
- GDUFA III Reauthorization
- GDUFA III Commitment Letter
- Generic Drug User Fee Amendments
- GDUFA Performance Reports