Search Results for keywords:"priority review voucher"

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Search Results: keywords:"priority review voucher"

  • 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.

  • Type:Notice
    Citation:89 FR 95219
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) has issued a priority review voucher to PTC Therapeutics Inc. for their product, KEBILIDI (eladocagene exuparvovec-tneq). This product is designed to treat both adult and pediatric patients with a condition known as aromatic L-amino acid decarboxylase deficiency. The priority review voucher is awarded under the Rare Pediatric Disease program, which encourages the development of treatments for rare diseases affecting children. The FDA is required to announce when such vouchers are given, as part of the criteria set by the Federal Food, Drug, and Cosmetic Act.

    Simple Explanation

    The FDA has given a special reward, like a golden ticket, to a company for making a new medicine that helps kids with a rare sickness. This reward helps the company get faster help to get their medicine ready for everyone who needs it.