FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: NOTICE OF APPROVAL OF PRODUCT UNDER VOUCHER: MATERIAL THREAT MEDICAL COUNTERMEASURE PRIORITY REVIEW VOUCHER; EYLEA HD (AFLIBERCEPT)

WASHINGTON, April 23 -- Food and Drug Administration has issued a notice called: Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; EYLEA HD (aflibercept).

The notice was published in the Federal Register on April 23 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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 ...