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 SupplementANDA : Abbreviated New Drug ApplicationPFC : Pre-Submission Facility CorrespondenceTA : Tentative ApprovalPAI : Pre-Approval InspectionPSG : Product-Specific GuidanceCRL : Complete Response LetterDMF : Drug Master File
Previous Fiscal Year Reports Related Resources
Content current as of:
12/08/2025
