85 FR 243 pgs. 81929-81930 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product
Type: NOTICEVolume: 85Number: 243Pages: 81929 - 81930
Pages: 81929, 81930Docket number: [Docket No. FDA–2020–N–0026]
FR document: [FR Doc. 2020–27760 Filed 12–16–20; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-0026]
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
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 IMCIVREE (setmelanotide) injection, manufactured by Rhythm Pharmaceuticals, Inc., meets the criteria for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-796-9856, email: althea.cuff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
[top] FDA is announcing the issuance of a priority review voucher to the sponsor of an
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 http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further information about IMCIVREE (setmelanotide) injection, go to the "Drugs@FDA" website at http://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: December 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27760 Filed 12-16-20; 8:45 am]
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