Generic Drugs Program 2023 Fiscal Year Web Posting

As outlined in the GDUFA III Commitment Letter, these GDUFA III performance metrics must be reported each fiscal year.

Original and PAS Review

	Review Time Goal	Actions Completed	Percent Completed on Time	Potential Range	On-Time Imminent Action +	Imminent Action Potential Range ++
Original ANDA Review
Standard Original ANDA Submissions	10 months	76 of 511	93%	15% to 99%	100%	15% to 100%
Priority Original ANDA Submissions (if applicant meets requirements of a PFC)	8 months	8 of 24	78%	29% to 92%	100%	33% to 100%
Priority Original ANDA Submissions (if applicant does not meet the requirements of a PFC)	10 months	19 of 115	100%	17% to 100%	100%	17% to 100%
Standard and Priority Original Facility not Ready with Reset	30 months	0	--	--	--	--
Amendment Review
Standard Major ANDA Amendments (if PAI is not required)	8 months	227 of 720	92%	31% to 99%	97%	31% to 99%
Standard Major ANDA Amendments (if PAI is required)	10 months	10 of 46	50%	13% to 86%	90%	20% to 98%
Priority Major ANDA Amendments (if PAI is not required)	6 months	57 of 116	93%	47% to 97%	95%	48% to 97%
Priority Major ANDA Amendments (if PAI is required and applicant meets the requirements of a PFC)	8 months	0	--	--	--	--
Priority Major ANDA Amendments (if PAI is required and applicant does not meet the requirements of a PFC)	10 months	3 of 14	100%	21% to 100%	100%	21% to 100%
Standard and Priority Minor ANDA Amendments	3 months	494 of 716	88%	62% to 91%	97%	68% to 98%
PAS Review
Standard PAS (if PAI is not required)	6 months	839 of 1400	99%	60% to 99%	99%	60% to 99%
Standard PAS (if PAI is required)	10 months	24 of 66	100%	36% to 100%	100%	36% to 100%
Priority PAS (if PAI is not required)	4 months	63 of 97	92%	61% to 95%	94%	61% to 96%
Priority PAS (if PAI is required and applicant meets the requirements of a PFC)	8 months	0	--	--	--	--
Priority PAS (if PAI is required and applicant does not meet the requirements of a PFC)	10 months	3 of 11	100%	27% to 100	100%	27% to 100
PAS Amendment Review
Standard Major PAS Amendment (if PAI is not required)	6 months	87 of 122	100%	71% to 100%	100%	71% to 100%
Standard Major PAS Amendment (if PAI is required)	10 months	4 of 10	100%	40% to 100%	100%	40% to 100%
Priority Major PAS Amendment (if PAI is not required)	4 months	4 of 6	100%	67% to 100%	100%	67% to 100%
Priority Major PAS Amendment (if PAI is required and applicant does not meet the requirements of a PFC)	10 months	0	--	--	--	--
Standard and Priority Minor PAS Amendments	3 months	174 of 224	97%	76% to 98%	99%	77% to 99%

+ = FDA considers an action to be an Imminent Action if an Approval or TA occurs within 60 days after the goal date.

++ = “Range” represents the minimum (all pending become late) and maximum (all pending reviewed on time) performance.

GDUFA Meeting Commitments

	Goal	Actions Completed	Percent Completed on Time	Potential Range
Product Development Meetings
Grant or deny Product Development Meeting requests	14 days	99 of 99	100%	100% to 100%
Conduct or provide written response to granted Product Development Meetings	120 days	56 of 71	100%	79% to 100%
Provide preliminary written comments before each Product Development Meeting unless FDA is providing a written response	5 days before meeting	29 of 37	100%	78% to 100%
Provide meeting minutes	30 days following the meeting	15 of 23	100%	65% to 100%
Pre-Submission Meetings
Grant or deny Pre-Submission Meeting Requests	30 days	9 of 9	89%	89% to 89%
Conduct granted Pre-Submission Meetings	Within 60 days from receipt of request	0	--	--
Provide preliminary written comments if appropriate to the purpose of the meeting	5 days before each meeting	0	--	--
Provide meeting minutes	Within 30 days of the meeting	0	--	--
PSG Teleconferences and Meetings
Conduct granted PSG Teleconferences	30 days	2 of 2	100%	100% to 100%
Grant or deny a meeting request for a Pre-Submission PSG Meeting	14 days	0	--	--
Conduct granted Pre-Submission PSG Meetings	Within 120 days from receipt of request	0	--	--
Grant or deny a meeting request for a Post-Submission PSG Meeting	14 days	0	--	--
Schedule granted Post-Submission PSG Meetings if the applicant has submitted an ANDA	Within 90 days from receipt of request	0	--	--
Mid-Cycle Review Meetings
Conduct Mid-Cycle Meetings	30 days	1 of 1	100%	100% to 100%
Conduct Enhanced Mid-Cycle Meeting	90 days	1 of 1	100%	100% to 100%
Post-CRL Teleconferences
Provide a scheduled date for a requested Post-CRL teleconference	14 days	65 of 65	91%	91% to 91%
Conduct requested Post-CRL teleconferences on the FDA-proposed date	30 days	61 of 65	98%	91% to 98%
Post-CRL Scientific Meetings
Provide a scheduled date for a requested Post-CRL Scientific Meeting	14 days	20 of 20	100%	100% to 100%
Conduct or provide written response to granted Post CRL Scientific Meeting	90 days	12 of 14	100%	86% to 100%

+ = “Range” represents the minimum (all pending become late) and maximum (all pending reviewed on time) performance.

DMF Review

	Count	Granted	Completed
DMF
Requests for review of a DMF prior to ANDA or PAS submission	12	9	3
Priority and non-priority "off-cycle" solicited DMF amendments reviewed	75	--	--

Imminent Actions

	Count
Imminent Actions +
Original Approvals that are Imminent Actions	53
Original TAs that are Imminent Actions	26

+ = FDA considers an action to be an imminent action if an Approval or TA occurs within 60 days after the goal date.

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

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