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    UNAPPROVED

    Traducere în limba română

    unapproved adjectiv

    (şi unapproved of) neaprobat.

     Exemple de propoziții și/sau fraze: 

    A category specifying that a product is marketed as unapproved vitamin product.

    (Marketed as Unapproved Vitamin Product, NCI Thesaurus)

    Device problems related to its use during an unapproved procedure, in an unapproved patient, or for which it is contraindicated, or not listed on the label.

    (Off-Label Unapproved or Contraindicated Device Use Evaluation Conclusion, Food and Drug Administration)

    A category specifying that a product is marketed as unapproved medical gas.

    (Marketed as Unapproved Medical Gas, NCI Thesaurus)

    A category specifying that a product is marketed as unapproved homeopathic product.

    (Marketed as Unapproved Homeopathic Product, NCI Thesaurus)

    An investigational device may be an approved device that is being studied for an unapproved use or efficacy.

    (Investigational Medical Device, NCI Thesaurus)

    A marketing category specifying that an unapproved drug product is manufactured and packaged exclusively for a Private Label Distributor, and not otherwise marketed by the drug product's manufacturer.

    (Marketed as Unapproved Drug Product Manufactured Exclusively for Private Label Distributor, NCI Thesaurus)

    The EUA is a statutory authority allowing the Secretary of the Department of Health and Human Services (HHS) to authorize the introduction into interstate commerce and the use of unapproved medical products or authorize unapproved uses of approved medical products intended for use in an actual or potential emergency, during an emergency declared under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Project BioShield Act of 2004 (Public Law 108-276).

    (Emergency Use Authorization, Food and Drug Administration)




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