Rules and Regulations. Notice
/register/2024/10/15/2024-23651·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2024-23651 · Docket No. FDA-2018-N-1262
Summary
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. 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 issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the supplemental application for KISQALI (ribociclib), approved September 17, 2024, meets the criteria for redeeming a priority review voucher.
Supplementary Information
FDA is announcing the approval of a product redeeming a rare pediatric disease priority review voucher. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will report the issuance of rare pediatric disease priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that the supplemental application (Supplement-18) for KISQALI (ribociclib) meets the redemption criteria. For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to . For further information about KISQALI (ribociclib), go to the “Drugs@FDA” website at . Dated: October 8, 2024. Eric Flamm, Acting Associate Commissioner for Policy. [FR Doc. 2024-23651 Filed 10-11-24; 8:45 am]