GDUFA Science and Research Outcomes for Fiscal Year 2021
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:
- Development of generic drug products
- Generation of evidence needed to support efficient review and timely approval of Abbreviated New Drug Applications (ANDAs)
- 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 ANDA 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 (IVIVC) 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 PSGs impacted by research
d. Number of publications, presentations, and posters that are relevant to this category
e. Number of workshops that communicate scientific advancements and regulatory advice to the generic drug industry
f. 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 (API) 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 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
b. Number of PSGs that provided new approaches to equivalence
c. Number of publications, presentations, and posters that are relevant to this category
The following are research outcomes from fiscal years 20181 , 2019, 2020 and 2021.
GDUFA research supporting the development of generic drug products
| Outcome type | Number FY2018 | Number FY2019 | Number FY2020 | Number FY2021 |
|---|---|---|---|---|
| Number of pre-ANDA meetings impacted by research | 62 | 93 | 92 | 113 |
| Number of Controlled Correspondences impacted by research | 113 | 178 | 291 | 457 |
| Number of PSGs impacted by research | 86 | 82 | 86 | 40 |
| Number of publications, presentations, and posters that are relevant to this category | 244 | 162 | 156 | 233 |
| Number of workshops that communicate scientific advances and regulatory advice to the generic drug industry | 8 | 5 | 5 | 14 |
| Number of other items that fall in this category (e.g., general guidances for industry) | 2 | 2 | 3 | 5 |
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 of pre-ANDA meetings impacted by research | 16 | 39 | 59 | 33 |
| Number of ANDA submissions impacted by research | 138 | 167 | 166 | 81 |
| Number of ANDA reviews impacted by research | 44 | 36 | 62 | 50 |
| Number of ANDA approvals impacted by research | 63 | 102 | 152 | 161 |
| Number of PSGs impacted by research | 29 | 35 | 48 | 11 |
| Number of publications, presentations, and posters that are relevant to this category | 82 | 92 | 100 | 102 |
GDUFA research supporting the evaluation of generic drug equivalence
| Outcome type | Number FY2018 | Number FY2019 | Number FY2020 | Number FY2021 |
|---|---|---|---|---|
| Number of pre-ANDA meetings impacted by research | 32 | 52 | 24 | 28 |
| Number of PSGs that provided new approaches to equivalence | 36 | 27 | 30 | 21 |
| Number of publications, presentations, and posters that are relevant to this category | 37 | 36 | 21 | 58 |
1FY2018 numbers were recalculated with the FY2019 methodology and thus differ from those originally reported for FY2018