FY 2022 GDUFA Science and Research Report
FY 2022 GDUFA Science and Research Report (PDF - 14 MB)
The FY 2022 GDUFA science and research report describes active research projects and outcomes organized in 13 scientific areas. In each area, we summarize the relevant research initiatives and highlight a research project that illustrates the types of scientific insights being developed. We also provide comprehensive lists of new, ongoing, and completed grants and contracts for research impacting each area, and of the research outcomes in that area generated during FY 2022. These outcomes include general guidances for industry and product-specific guidances (PSGs) published in FY 2022 that were supported by research in each area, as well as lists of scientific journal articles, posters, and presentations.
Table of Contents
(Each link below will open a 14 MB PDF)
- Introduction
- Joint Directors' Message
- Ophthalmic Products
- Complex Mixtures and Peptide Products
- Long-Acting Injectable, Insertable or Implantable Products
- Complex Injectables, Formulations and Nanomaterials
- Inhalation and Nasal Products
- Topical Products
- Locally-Acting Physiologically Based Pharmacokinetic Modeling
- Quantitative Clinical Pharmacology
- Oral Absorption Models and Bioequivalence
- Patient Substitution of Generic Drugs
- Abuse-deterrent Opioid Drug Products
- Data Analytics
- Drug-Device Combination Products
- Acknowledgements
Directors of CDER’s Office of Generic Drugs and Office of Pharmaceutical Quality
Susan Rosencrance, Ph.D.
Acting Director of CDER’s Office of Generic Drugs
Michael Kopcha, Ph.D., R.Ph.
Director of CDER’s Office of Pharmaceutical Quality
The GDUFA science and research program is particularly important for certain pharmaceutical products, known as complex products, which are harder to develop as generics. Complex products often have few generics, or none at all. In the absence of market competition among generic alternatives, these medicines can be so expensive that patients who need them may not be able to afford them. The GDUFA science and research program supports the development of innovative methodologies and more efficient tools to help establish drug equivalence standards that facilitate the development of safe, effective, and high-quality generic products.
The outcomes from GDUFA-funded research expand our understanding of drug products, including complex products, and often contribute to the development of advanced methods to characterize product quality and performance. These methods may play a critical role in determining how FDA evaluates the quality and bioequivalence (BE) of complex generic products and can establish the scientific basis for novel and more efficient pathways by which to develop generic products. FDA’s recommendations related to BE issues and product quality are communicated to the generic industry through the continual publication of new and revised product-specific guidances (PSGs), as well as general guidances for industry.
We are deeply grateful to all of our collaborators within FDA and at institutions around the world, and to many throughout the global generic drug industry, for the success of the GDUFA science and research program. The continual advances and emerging issues in pharmaceutical science and manufacturing provide ongoing challenges for generic product development. We remain confident that our collaborative engagements to advance the GDUFA science and research program are the most effective way to address these scientific challenges for generics, and we look forward with optimism that the outcomes of this research program will continue to promote generic competition as a key part of FDA’s Drug Competition Action Plan and enhance patient access to high-quality, safe, and effective medicines.
Read the full FY 2022 GDUFA Science and Research Report Joint Directors' Message here.