Search Results for keywords:"fast track review process"

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Search Results: keywords:"fast track review process"

  • Type:Notice
    Citation:90 FR 17066
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) has approved a product called EYLEA HD (aflibercept) by redeeming a priority review voucher. This approval falls under the Federal Food, Drug, and Cosmetic Act, which allows the FDA to issue priority review vouchers to sponsors of certain medical countermeasure product applications. The vouchers are given to products that might address material threats and can be redeemed to speed up the review process of a product application. EYLEA HD meets the necessary criteria set by this act for a priority review voucher.

    Simple Explanation

    The FDA let a new medicine called EYLEA HD get checked faster because it might help with really important health problems. They have a special ticket that lets them move to the front of the line.