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GDUFA Science and Research Outcomes for Fiscal Year 2023

As part of the enhanced accountability and reporting commitments in the Generic Drug User Fee Amendments of 2017 (GDUFA II), FDA prepares annual outcome reports on the extent to which GDUFA science and research-funded projects support:

  1. Development of generic drug products
  2. Generation of evidence needed to support efficient review and timely approval of Abbreviated New Drug Applications (ANDAs)
  3. Evaluation of generic drug equivalence

Aggregate metrics of research outcomes are reported for each of the three categories listed above within summary tables in this outcomes report (and in outcomes reports for other fiscal years in GDUFA II). A separate GDUFA Science and Research Report for each fiscal year during GDUFA II includes more details about the outcomes in each category, including lists of publications, presentations, and posters, links to Product-Specific Guidances (PSGs), and information about workshops at which scientific advancements and regulatory advice were communicated to the generic drug industry.

1. GDUFA research supporting the development of generic drug products

This category describes research outcomes that support the development of generic drug products (prior to abbreviated new drug application [ANDA] submission or re-submission). Examples of research in this category include the development of a new analytical method for improved product characterization or the development of an in vitro-in vivo correlation that informs formulation optimization.

Aggregate metrics of research outcomes under this category include:

a. Number of pre-ANDA meetings impacted by research
b. Number of Controlled Correspondences impacted by research
c. Number of product-specific guidances (PSGs) impacted by research
d. Number of post-complete response letters (CRL) Scientific Meetings
e. Number of workshops that communicate scientific advancements and regulatory advice to the generic drug industry
f. Number of publications, presentations, and posters that are relevant to this category
g. Number of other items that fall in this category (e.g., general guidances for industry)

2. GDUFA research supporting the generation of evidence needed to support efficient review and timely approval of ANDAs

This category describes research outcomes that support the generation or review of data included in an ANDA. Examples of research in this category include the development of an analytical method that demonstrates active pharmaceutical ingredient sameness or the development of a new bioequivalence study design.

Aggregate metrics of research outcomes under this category include:

a. Number of pre-ANDA meetings impacted by research
b. Number of ANDA submissions impacted by research
c. Number of ANDA reviews impacted by research
d. Number of ANDA approvals impacted by research
e. Number of PSGs impacted by research
f. Number of post-CRL Scientific Meetings
g. Number of publications, presentations, and posters that are relevant to this category

3. GDUFA research supporting the evaluation of generic drug equivalence

This category describes research outcomes that support changes to equivalence standards for ANDA review or the re-evaluation of equivalence of approved products. Examples of research in this category include alternative methods to demonstrate equivalence.

Aggregate metrics of research outcomes under this category include:

a. Number of pre-ANDA meetings impacted by research
b. Number of controlled correspondences discussing alternative bioequivalence approaches
c. Number of PSGs that provided new approaches to equivalence
d. Number of post-CRL Scientific Meetings
e. Number of publications, presentations, and posters that are relevant to this category

The following are research outcomes from fiscal years 20181, 2019, 2020, 2021, 2022, 2023.

GDUFA research supporting the development of generic drug products

Outcome type Number FY2018 Number FY2019 Number FY2020 Number FY2021 Number FY2022 Number FY2023
Number of pre-ANDA meetings impacted by research 62 93 92 113 92 89
Number of Controlled Correspondences impacted by research 113 178 291 972 137 309
Number of PSGs impacted by research 86 82 86 40 73 19
Number of Post-CRL Scientific Meetings na na na na na 2
Number of workshops that communicate scientific advances and regulatory advice to the generic drug industry 8 5 5 14 17 19
Number of publications, presentations, and posters that are relevant to this category 244 162 156 233 169 301
Number of other items that fall in this category (e.g., general guidances for industry) 2 2 3 5 1 10

GDUFA research supporting the generation of evidence needed to support efficient review and timely approval of ANDAs

Outcome type Number FY2018 Number FY2019 Number FY2020 Number FY2021 Number FY2022 Number FY2023
Number of pre-ANDA meetings impacted by research 16 39 59 33 22 46
Number of ANDA submissions impacted by research 138 167 166 81 65 183
Number of ANDA reviews impacted by research 44 36 62 50 65 80
Number of ANDA approvals impacted by research 63 102 152 161 126 167
Number of PSGs impacted by research 29 35 48 11 65 33
Number of Post-CRL Scientific Meetings na na na na na 1
Number of publications, presentations, and posters that are relevant to this category 82 92 100 102 68 212

GDUFA research supporting the evaluation of generic drug equivalence

Outcome type Number FY2018 Number FY2019 Number FY2020 Number FY2021 Number FY2022 Number FY2023
Number of pre-ANDA meetings impacted by research 32 52 24 28 50 33
Number of controlled correspondences discussing alternative BE approaches na na na na na 32
Number of PSGs that provided new approaches to equivalence 36 27 30 21 78 67
Number of Post-CRL Scientific Meetings na na na na na 2
Number of publications, presentations, and posters that are relevant to this category 37 36 21 58 140 118

1 FY2018 numbers were recalculated with the FY2019 methodology and thus differ from those originally reported for FY2018
2 FY2021 numbers differ from those originally reported for FY2021 due to the correction of an administrative error in FY2021 data

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