FDA Priority Review Costs Remain Stable While Voucher Fee Ticks Up
Formula was changed to better calculate the cost of a priority review, FDA says.
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Next fiscal year will be a good one to redeem a voucher, and probably to qualify for one as well.
Priority review ticket might be used on Type 2 diabetes combo LixiLan, expected to be filed later this year.
Even after paying BioMarin $67.5 million for the voucher itself, the firms still don’t know how much FDA will charge for a chance to get Praluent to market faster.