Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; EYLEA HD (aflibercept)
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Issuing agencies
Abstract
The Food and Drug Administration (FDA) is announcing the 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 material threat medical countermeasure (MCM) 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 application for EYLEA HD (aflibercept), approved August 18, 2023, meets the criteria for redeeming a priority review voucher.
Full Text
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<title>Federal Register, Volume 90 Issue 77 (Wednesday, April 23, 2025)</title>
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[Federal Register Volume 90, Number 77 (Wednesday, April 23, 2025)]
[Notices]
[Pages 17066-17067]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-06969]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1262]
Notice of Approval of Product Under Voucher: Material Threat
Medical Countermeasure Priority Review Voucher; EYLEA HD (aflibercept)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
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 material threat
medical countermeasure (MCM) 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 application for
EYLEA HD (aflibercept), approved August 18, 2023, meets the criteria
for redeeming a priority review voucher.
FOR FURTHER INFORMATION CONTACT: Andrea Gormley, Counter-Terrorism and
Emergency Coordination Staff, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., 2nd Floor,
Silver Spring, MD 20993-0002, 301-796-2210 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION: Under section 565A of the FD&C Act (21
U.S.C. 360bbb-4a), FDA will report the issuance of material threat MCM
priority review vouchers and the approval of products for which a
voucher was redeemed. FDA has determined that the application for EYLEA
HD (aflibercept) meets the redemption criteria.
For further information about the material threat MCM Priority
Review Voucher Program and for a link to the
[[Page 17067]]
full text of section 565A of the FD&C Act, go to <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions#prv</a>. For
further information about EYLEA HD (aflibercept), go to the
``Drugs@FDA'' website at <a href="http://www.accessdata.fda.gov/scripts/cder/daf/">http://www.accessdata.fda.gov/scripts/cder/daf/</a>.
Dated: April 16, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-06969 Filed 4-22-25; 8:45 am]
BILLING CODE 4164-01-P
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