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FY 2018 GDUFA Science and Research Outcomes

Each year, FDA prepares annual reports on the science and research-funded projects conducted under the Generic Drug User Fee Amendments of 2017 (GDUFA II) regulatory science program.  These reports provide greater transparency regarding the important work the Agency engages in to advance the science of generic drugs and provide generic drug developers, applicants, and FDA reviewers essential tools and information to help expedite the availability of high-quality, lower-cost safe and effective generic drugs.   

The agency is committed to reporting on research outcomes (or results) from projects that have either ended or were active throughout a given fiscal year.

As described in the GDUFA II Commitment Letter, this research supports:

  • the development of generic drug products
  • the generation of evidence needed to support efficient review and timely approval of Abbreviated New Drug Applications (ANDAs)
  • 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. An example of research in this category includes development of a new analytical method for improved product characterization. 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. Number 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 active pharmaceutical ingredient (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. Number 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 unapproved and approved products. 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 2018.

GDUFA research supporting the development of generic drug products

Outcome type

Number

Number of pre-ANDA meetings impacted by research

50

Number of Controlled Correspondences impacted by research

90

Number of PSGs that were impacted by research

38

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

214

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

8

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

Outcome type

Number

Number of pre-ANDA meetings impacted by research

16

Number of ANDA submissions impacted by research

62

Number of ANDA reviews impacted by research

35

Number of ANDA approvals impacted by research

59

Number of PSGs that were impacted by research

15

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

111

GDUFA research supporting the evaluation of generic drug equivalence

Outcome type

Number

Number of pre-ANDA meetings impacted by research

2

Number of PSGs that provided new approaches to equivalence

24

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

45