FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ISSUANCE OF PRIORITY REVIEW VOUCHER; RARE PEDIATRIC DISEASE PRODUCT; MODESYO (DORDAVIPRONE)

WASHINGTON, Aug. 28 -- Food and Drug Administration has issued a notice called: Issuance of Priority Review Voucher; Rare Pediatric Disease Product; MODESYO (dordaviprone).

The notice was published in the Federal Register on Aug. 28 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: 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) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the prio...