Search Results for keywords:"material threat medical countermeasure"

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Search Results: keywords:"material threat medical countermeasure"

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  • 2025-06970 — Issuance of Priority Review Voucher; Material Threat Medical Countermeasure Product; EBANGA
    Type:Notice
    Citation:90 FR 17071
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) has announced that a priority review voucher has been issued to Ridgeback Biotherapeutics, LP, for their product EBANGA. This product, approved on December 21, 2020, is used to treat infections caused by the Zaire ebolavirus. The priority review voucher is part of a program authorized by the Federal Food, Drug, and Cosmetic Act to expedite review processes for material threat medical countermeasures. More information about this program and product can be found on the FDA's website.

    Simple Explanation

    The FDA gave a special "fast pass" to a company that makes a medicine called EBANGA, which helps treat a really bad virus, so they can get quicker approval for another important medicine in the future.

  • 2025-06969 — Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher; EYLEA HD (aflibercept)
    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.