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)
Grants
- Development of Advanced Analytical Methods for Analyzing Diastereomer Compositions in Oligonucleotides (U01) Clinical Trial Not Allowed (RFA-FD-22-013 Applications Due: 02/07/2022)
- Cutaneous Pharmacokinetics (PK) Based Approaches to Demonstrate Bioequivalence of Topical Products (U01) Clinical Trial Required (RFA-FD-22-017 Applications Due: 03/31/2022)
- PBPK Modeling to Support an Assessment of Bioequivalence for Locally-Acting Drugs in the Gastrointestinal Tract (U01) Clinical Trial Optional (RFA-FD-22-012 Applications Due: 03/31/2022)
- In Vitro Based Approaches to Evaluate the Bioequivalence of Prospective Generic Rectal and Vaginal Products (U01) Clinical Trial Not Allowed (RFA-FD-22-014 Applications Due: 03/31/2022)
- Investigating the In Vivo Behavior and In Vitro Characteristics of a Purportedly Gastro-Retentive Extended Release Formulation to Elucidate Considerations Relevant to Generic Products (U01) Clinical Trials Required (RFA-FD-22-018 Applications Due: 03/31/2022)
- In Vitro Approaches to Evaluate and Compare the Adhesion Performance of Transdermal and Topical Delivery Systems (TDS) (U01) Clinical Trial Required (RFA-FD-22-015 Applications Due: 03/31/2022)
- Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial Optional (RFA-FD-22-016 Applications Due: 03/31/2022)
ORISE Fellowships
Currently open Oak Ridge Institute for Science and Education (ORISE) fellowship announcements:
- FDA In Vitro and In Vivo Bioequivalence Fellowship NEW
- FDA Characterization of Drug Product in Soft Food Fellowship
- Data Analytics Research for Product-Specific Guidances
- FDA Global Maufacturing Fellowship
- FDA Modeling of Dry Powder Inhaler (DPI) Drug Delivery
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