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

  1. the development of generic drug products
  2. the generation of evidence needed to support efficient review and timely approval of Abbreviated New Drug Applications (ANDAs)
  3. the evaluation of generic drug equivalence

The following types of research outcomes are reported for each of the three categories listed above:

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 development of a new analytical method for improved product characterization or development of an in vitro-in vivo correlation (IVIVC) that informs formulation optimization. Types of research outcomes that are reported under this category include:

    1. Number of pre-ANDA meetings impacted by research
    2. Number of Controlled Correspondence impacted by research
    3. Number and links to Product-Specific Guidances (PSGs) that were impacted by research
    4. List of publications, presentations, and external posters that are relevant to this category
    5. Workshops that communicate scientific advances and regulatory advice to the generic industry
    6. Other items that fall in this category (i.e., general guidance)

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 development of an analytical method that demonstrates API sameness or development of a new bioequivalence study design. Types of research outcomes that are reported under this category include:

  1. Number of ANDA submissions impacted by research
  2. Number of ANDA reviews impacted by research
  3. Number of ANDA approvals impacted by research
  4. List of publications, presentations, and external posters that are relevant to this category
  5. Other items that fall in this category (i.e., review tools)

3. GDUFA research supporting the evaluation of generic drug equivalence

This category describes research outcomes that support evaluation of equivalence of approved products or changes to equivalence standards for ANDA review. Examples of research in this category include alternative methods to demonstrate equivalence. Types of research outcomes that are reported under this category include:

  1. Number of and links to PSGs that provided new approaches to equivalence
  2. List of publications, presentations, and external posters that are relevant to this category
  3. Other items that fall in this category (i.e., general guidances, review tools) 

Annual outcome reports describe research outcomes at an aggregate level and not at the individual project level. Information on the specific outcome types that resulted from a specific project can be found from the annual GDUFA Science and Research Report.

The following are research outcomes from fiscal year 20181 and 2019.

GDUFA research supporting the development of generic drug products

Outcome type

Number FY2018

Number FY2019

Number of pre-ANDA meetings impacted by research

62

93

Number of Controlled Correspondences impacted by research

113

178

Number of PSGs that were impacted by research

86

82

List of publications, presentations, and external posters that are relevant to this category

244

162

Workshops that communicate scientific advances and regulatory advice to the generic industry

8

5

Other items that fall in this category (i.e., general guidance)

2

2

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

Outcome type

Number FY2018

Number FY2019

Number of pre-ANDA meetings impacted by research

16

39

Number of ANDA submissions impacted by research

138

167

Number of ANDA reviews impacted by research

44

36

Number of ANDA approvals impacted by research

63

102

Number of PSGs that were impacted by research

29

35

List of publications, presentations and external posters that are relevant to this category

82

92

GDUFA research supporting the evaluation of generic drug equivalence

Outcome type

Number FY2018

Number FY2019

Number of pre-ANDA meetings impacted by research

32

52

Number and links to PSGs that provided new approaches to equivalence

36

27

List of publications, presentations and external posters that are relevant to this category

37

36

1FY2018 numbers were recalculated with the FY2019 methodology and thus differ from those previously reported