Search Results for citation:"90 FR 2008"

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Search Results: citation:"90 FR 2008"

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  • 2025-00357 — Advisory Committee; Antimicrobial Drugs Advisory Committee; Renewal
    Type:Notice
    Citation:90 FR 2008
    Reading Time:about 3 minutes

    The Food and Drug Administration (FDA) has renewed the charter for the Antimicrobial Drugs Advisory Committee until October 7, 2026. This independent advisory group helps the FDA ensure that drugs used to treat infectious diseases are safe and effective. The committee includes 13 voting members with expertise in fields like infectious diseases and internal medicine. The renewal is considered important to support public interest and ensure continued expert advice on drug safety and effectiveness.

    Simple Explanation

    The FDA is keeping a special group of experts, called the Antimicrobial Drugs Advisory Committee, to help make sure that medicines for infections are safe and work well, and this group will continue to do their job until 2026.

  • 2025-00340 — Issuance of Priority Review Voucher; Rare Pediatric Disease Product; CRENESSITY (crinecerfont)
    Type:Notice
    Citation:90 FR 2008
    Reading Time:about a minute or two

    The Food and Drug Administration (FDA) has issued a priority review voucher to the sponsor of the rare pediatric disease product, CRENESSITY (crinecerfont). This voucher is awarded under the Federal Food, Drug, and Cosmetic Act, which allows such recognition for approved products meeting specific criteria. CRENESSITY is manufactured by Neurocrine Biosciences, Inc., and was approved on December 13, 2024, for the treatment of classic congenital adrenal hyperplasia in adults and children aged four and older. This announcement fulfills FDA's requirement to publish notice of such awards.

    Simple Explanation

    The FDA gave a special ticket to a medicine called CRENESSITY that helps children with a rare illness so it could be checked faster, and they had to tell everyone they did this.