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Priority Review Voucher Program For Rare Pediatric Diseases Extended As FDA Lowers Fee

Executive Summary

Next fiscal year will be a good one to redeem a voucher, and probably to qualify for one as well.

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Priority Review Voucher Fee Rises 4.6% For Fiscal 2018

As of Oct. 1, the fee for rare pediatric disease and tropical disease priority review vouchers will be $2.83m; the increase follows a slight decline in FY 2017.

Drug Pricing Bill May Make Six-Month ANDA Review Slower Than Eight-Month Review

Legislation would create a potential second priority review pathway for generics, as well as another priority review voucher program, but may not be as enticing as GDUFA II proposal.

Drug Pricing Bill May Make Six-Month ANDA Review Slower Than Eight-Month Review

Legislation would create a potential second priority review pathway for generics, as well as another priority review voucher program, but may not be as enticing as GDUFA II proposal.

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