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) applications are accepted on a continuous basis (see FDABAA-23-00123)
Grant Forecasts
- Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed [FOR-FD-23-017]
- Evaluation of Oral Modified Release Dosage Forms to Support the Approval of Additional Strengths (U01) Clinical Trial Not Allowed [FOR-FD-23-018]
- In Vivo Regional Deposition Measurements for Supporting Model Validation [FOR-FD-23-019]
- Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling [FOR-FD-23-021]
- Designing and Performing a Virtual Bioequivalence Trial for Physiologically-Based Pharmacokinetic and other Mechanism-Based Models [FOR-FD-23-020]
- Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed [FOR-FD-23-022]
ORISE Fellowships
Currently open Oak Ridge Institute for Science and Education (ORISE) fellowship announcements:
- FDA Modeling and Simulation Fellowship - Zintellect - Climb Higher
- FDA In Vitro and In Vivo Bioequivalence Fellowship - Zintellect - Climb Higher
- FDA Bioequivalence of Complex Generic Products Fellowship
- FDA Product Specific Guidance and Research Fellowship - Zintellect - Climb Higher