Generic Drug Research-Related Guidances & Reports
The research studies conducted under the Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new generic products. FDA's Office of Generic Drugs also publishes an annual research report each fiscal year, summarizing the research activities and outcomes from extramural and intramural projects.
Notable Guidances Related to GDUFA Science and Research Projects
FDA publishes product-specific guidances describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs Tto facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support Abbreviated New Drug Application (ANDA) approval. Recent product-specific recommendations for complex products developed as a result of regulatory science projects include:
- Draft Guidance: Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs
- Draft Guidance: Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs
- Draft Guidance: ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry
- Draft Guidance: Fluorometholone ophthalmic suspension
- Draft Guidance: Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs
GDUFA Science and Research Reports
These annual reports describe the activities and progress in each of five regulatory science priority areas.
- FY 2021 GDUFA Science and Research Report
- FY 2020 GDUFA Science and Research Report
- FY 2019 GDUFA Science and Research Report
- FY 2018 GDUFA Science and Research Report
- FY 2017 GDUFA Science and Research Report
- FY 2016 GDUFA Science and Research Report
- FY 2015 GDUFA Science and Research Report
GDUFA Science and Research Outcomes
A compilation of all research outcomes for a given fiscal year.