For Industry

FY 2015 GDUFA Regulatory Science Funding Announcements

As part of the Generic Drug User Fee Amendments (GDUFA) of 2012, The Food and Drug Administration held a public meeting on May 16, 2014 to seek input from a variety of stakeholders in developing the FY 2015 Regulatory Science Initiatives. The resulting FY 2015 research priorities are: post-market evaluation of generic drugs, equivalence of complex products, equivalence of locally-acting products, therapeutic equivalence evaluation and standards, and computational and analytical tools. 

Scientific research opportunities, funded through the GDUFA Regulatory Science Research Program, are now open (these announcements can also be found Grants.gov and FedBizOpps.gov):

 
RFA-FD-15-006 “Dissolution Methods for Long-acting Levonorgestrel Intrauterine System (U01)" is now posted to NIH Guide and Grants.gov. The links are below. 
 
RFA-FD-15-007 “Dissolution Methods for Long-acting Periodontal Drug Products (U01)" is now posted to NIH Guide and Grants.gov. The links are below. 
 
RFA-FD-15-008 “Pharmacometric Modeling and Simulation for Long Acting Injectable Products (U01)” is now posted to NIH Guide and Grants.gov. The links are below. 
 
 

                                              

Page Last Updated: 02/24/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.