Priority Review Vouchers Could Be Used Frequently Next Year
This article was originally published in The Pink Sheet Daily
FDA requests enough pediatric rare disease priority review voucher user fees to fund three redemptions in fiscal year 2016.
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FDA can't keep pace with requests, placing more pressure on sponsors to ensure submissions are complete.
Priority review ticket might be used on Type 2 diabetes combo LixiLan, expected to be filed later this year.
Committee members didn’t even vote on any amendments besides the manager’s package, but proposals floated and withdrawn offer glimpse at potential fights to come.