Priority Review Vouchers For Pediatric Rare Disease: Will Popularity Force A Quick Halt?
Based on designations, FDA already could have enough products in the pipeline to trigger the mandatory program stop and assessment.
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Priority Review Vouchers Could Be Used Frequently Next Year
FDA requests enough pediatric rare disease priority review voucher user fees to fund three redemptions in fiscal year 2016.
Review Cost For Sanofi/Regeneron’s PCSK9 Inhibitor Remains Uncertain
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.
Adaptive Trials Guidance For Pediatric Drugs Will Draw On Device Advice
FDA’s centers may slingshot development work on how best to use control data.