FY 2017 User Fees for Priority Disease Review Vouchers/ GDUFA Public Meeting
1. Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2017
FDA is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2017. These vouchers are awarded to the sponsors of rare pediatric disease product applications that meet all of the requirements of this program, are submitted 90 days or more after July 9, 2012, and upon FDA approval of such applications. This notice establishes the rare pediatric disease priority review fee rate for FY 2017 and outlines the payment procedures for such fees.
FDA is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2017. These vouchers are awarded to the sponsors of rare pediatric disease product applications that meet all of the requirements of this program, are submitted 90 days or more after July 9, 2012, and upon FDA approval of such applications. This notice establishes the rare pediatric disease priority review fee rate for FY 2017 and outlines the payment procedures for such fees.
2. Fee for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2017
FDA announcing the fee rates for using a tropical disease priority review voucher for fiscal year (FY) 2017. These vouchers are awarded to the sponsors of certain tropical disease product applications, submitted after September 27, 2007, upon FDA approval of such applications. This notice establishes the tropical disease priority review fee rate for FY 2017.
3. Generic Drug User Fees; Public Meeting; Request for Comments
FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of GDUFA, which authorizes FDA to collect user fees related to human generic drugs and use them for the process of the review of certain generic human drug applications and associated submissions, to conduct related inspections, and to engage in other related activities for FYs 2018 to 2022. Without new legislation, FDA will no longer be able to collect user fees to fund the human generic drug review process for future fiscal years.
The public meeting will be held on October 21, 2016, from 9 a.m. to 5 p.m. at the FDA White Oak Campus in Silver Spring MD. Submit electronic or written comments to the public docket by November 7, 2016.
.png)
No hay comentarios:
Publicar un comentario