Issuance of Priority Review Voucher; Rare Pediatric Disease Product

Özet

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of rare pediatric disease product applications that meet certain criteria. FDA has determined that SPINRAZA (nusinersen), manufactured by Biogen Inc., meets the criteria for a priority review voucher.