💊FDA Issues Priority Review Voucher for CRENESSITY (Crinecerfont)
Issuance of Priority Review Voucher; Rare Pediatric Disease Product; CRENESSITY (crinecerfont)
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 priority review voucher. FDA has determined that CRENESSITY (crinecerfont), approved on December 13, 2024, manufactured by Neurocrine Biosciences, Inc., meets the criteria for a priority review voucher.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The announcement of the priority review voucher related to CRENESSITY (crinecerfont) signifies compliance and regulatory requirements under the FD&C Act, impacting business owners in the pharmaceutical sector. Companies engaged in developing rare pediatric disease products can benefit from understanding the criteria for gaining priority review, which could enhance product development strategies and timelines.