FY2016 GDUFA Regulatory Science Funding Announcements
As part of the Generic Drug User Fee Amendments of 2012 (GDUFA), the Food and Drug Administration held a public meeting on June 5, 2015 to seek input from a variety of stakeholders in developing the FY2016 Regulatory Science Initiatives.
The following scientific research opportunities, which support the FY2016 Regulatory Science Priorities, are currently open:
Grants:
- RFA-FD-16-010: Use of imaging and digital image analysis software/s to evaluate transdermal irritation and non-inferiority of generic transdermal products (U01) (Full announcement)
- RFA-FD-16-011: Generic Drug Substitution in Special Populations (U01) (Full announcement)
- RFA-FD-16-012: Investigation of Peptide-Polymer Interaction in Poly(lactide-co-glycolide) Microspheres (U01) (Full announcement)
- RFA-FD-16-018: Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (U01) (Full announcement)
- RFA-FD-16-024: Assessment of Intersubject Variability in Small Airway Delivery with Oral Inhalation Drug Products (U01) (Full announcement)
- RFA-FD-16-025: Integrating supersaturation-precipitation mechanisms in mechanistic oral absorption models for predicting in vivo performance of supersaturating formulations (U01) (Full announcement)
- RFA-FD-16-026: Implementing Population Pharmacokinetic Modeling Algorithm in Physiologically-based Pharmacokinetic Models to Allow Parameter Estimation at Individual Data Level (U01) (Full announcement)
- RFA-FD-16-028: Bioequivalence of Topical Products: Comparing Dermal Pharmacokinetics by Microdialysis or Microperfusion Techniques (U01) (Full announcement)
- RFA-FD-16-029: Bioequivalence of Topical Products: Comparing Epidermal Pharmacokinetics by Spectroscopic Imaging Techniques (U01) (Full announcement)
- RFA-FD-16-033: Study of Fluid Amounts Taken with Oral Drug Products (U01) (Full announcement)