FY 2021 GDUFA Science and Research Report
The FY 2021 GDUFA Science and Research report provides detailed results for 13 areas of focus, each including a summary of research activities, research highlights, comprehensive lists of new, ongoing, and completed grants and contracts, and outcomes generated from the GDUFA-funded Science and Research program in FY 2021. The outcomes include a list of general guidances and product-specific guidances (PSGs) issued in FY 2021 that resulted from relevant research, as well as lists of journal articles, posters, and presentations given in FY 2021. Additional information on outcomes from the GDUFA Science and Research program are shared in the separate GDUFA Science and Research Outcomes Reports, posted here.
Table of Contents
- Joint Directors' Message
- Abuse-Deterrent Opioid Products
- Complex Injectables, Formulations, and Nanomaterials
- Complex Mixtures and Peptide Products
- Data Analytics
- Drug-Device Combination Products
- Inhalation and Nasal Products
- Locally-Acting Physiologically-Based Pharmacokinetic Modeling
- Long-Acting Injectable and Implant Products
- Ophthalmic Products
- Oral Absorption Models and Bioequivalence
- Patient Substitution of Generic Drugs
- Quantitative Clinical Pharmacology
- Topical Dermatological Products
- Acknowledgements
Directors of CDER’s Office of Generic Drugs and Office of Pharmaceutical Quality
Sally Choe, Ph.D.
Director of CDER’s Office of Generic Drugs
Michael Kopcha, Ph.D., R.Ph.
Director of CDER’s Office of Pharmaceutical Quality
FY 2021 GDUFA Science and Research Report (PDF - 18 MB)
The GDUFA Science and Research program supports the development of innovative methodologies and more efficient tools to help establish drug equivalence standards and support the development of safe, effective, and high-quality generic drug products for the American public. This research 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 outcomes from GDUFA-funded research expand our understanding of these 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 of complex generic products and establish the scientific basis for novel and more efficient pathways by which to develop complex generics. Bioequivalence and quality recommendations are communicated to the generic industry, such as 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 our stakeholders throughout the global generic drug industry. There remain numerous challenges to face, and we look forward with optimism and we remain confident that our collaborations to advance the GDUFA Science and Research Program are the most effective way to address scientific challenges for complex generics, and to enhance patient access to high quality, safe, and effective medicines.
Read the full FY 2021 GDUFA Science and Research Report Joint Directors' Message here.