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-22-00123)
ORISE Fellowships
Currently open Oak Ridge Institute for Science and Education (ORISE) fellowship announcements:
- 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
Grant Forecasts
- Cutaneous pharamcokinetic-based approaches to establish bioequivalence of topically applied drug products
- In Vitro Based Approaches to Evaluate the Bioequivalence of Generic Rectal and Vaginal Products
- Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products
- In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS or drug patches)
- PBPK modeling to support assessment of bioequivalence of locally acting drugs in the gastrointestinal tract
- Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery
- Development of advanced analytical methods for the characterization of complex generics