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

Related Resources

 

  • Content current as of:

    06/03/2025

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