GDUFA up for review, agency says

SILVER SPRING, Md. - The Food and Drug Administration recently announced it will be hosting a public meeting seeking input on the reauthorization of the Generic Drug User Fee Amendments on June 15 here. 

 

According to the agency, the legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years.  

 

FDA is inviting the public to comment on the GDUFA program and provide suggestions regarding the features FDA should propose for the next GDUFA program, especially the assessment of the overall performance of the GDUFA program to date, and aspects of GDUFA that should be retained, changed or discontinued to further strengthen and improve the program.