FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ISSUANCE OF PRIORITY REVIEW VOUCHER; RARE PEDIATRIC DISEASE PRODUCT; KRESLADI (MARNETEGRAGENE AUTOTEMCEL)

WASHINGTON, April 2 -- Food and Drug Administration has issued a notice called: Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KRESLADI (marnetegragene autotemcel).

The notice was published in the Federal Register on April 2 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 awa...