Generic Drug Research Collaboration Opportunities
The FDA Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating within FDA as well as externally through grants or contracts.
Contracts
- Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science applications are accepted on a continuous basis (see FDABAA-24-00123)
Grant Forecasts
- Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed (RFA-FD-24-005)
- Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional (RFA-FD-24-006)
- Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed (RFA-FD-24-007)
- Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required) (RFA-FD-24-008)
- Improving Predictability of Food-Drug and Drug-Drug Interaction Risks by Utilizing In Vitro Simulated Gastrointestinal Dissolution Model for High-Risk Oral Drug Products (U01) Clinical Trial Optional (RFA-FD-24-09)
- Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed (RFA-FD-24-010)
- Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed (RFA-FD-24-011)
ORISE Fellowships
Currently open Oak Ridge Institute for Science and Education (ORISE) fellowship announcements:
- FDA Drug-Device Combination Products and Human Factors Fellowship
- FDA Modeling and Simulation Fellowship
- FDA In Vitro and In Vivo Bioequivalence Fellowship
- FDA Bioequivalence of Complex Generic Products Fellowship
- FDA Product Specific Guidance and Research Fellowship