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

Other Collaboration Opportunities

• The Center for Research on Complex Generics