Monday, August 24, 2015 1:35:51 PM
About the Rare Pediatric Disease Priority Review Voucher Program
The program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. A PPRV may be issued to the sponsor of a rare pediatric disease product application and would entitle the holder to priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and could lead to an expedited approval. The sponsor receives the PPRV upon approval of the rare pediatric disease product application and it can be sold without limitation.
- See more at: http://cellceutix.com/cellceutix-requesting-meeting-with-fda-on-kevetrin-for-pediatric-retinoblastoma/#sthash.rF0vBMrr.dpuf
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