Health / Medical Topics

    Product Problem

    An issue with quality, authenticity, performance, or/and safety of medication or medical device. The concept encompasses any problems that may occur during manufacturing, shipping, storage, or use of the medical product including but not limited to such concerns as suspect counterfeit product, product contamination, super potent or subpotent medication, defective item or its component, poor packaging or product confusion, questionable stability, device failure or malfunction, and labeling concerns. (NCI Thesaurus)




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    Specifies whether the product qualifies under the 1938 Grandfather Clause, contained in section 20l(p)(l) of the U.S. Federal Food, Drug and Cosmetic…
    The date (and time), assigned by the manufacturer, on which the product should not be used.
    An indication of the amount of the ingredient contained in a reference amount of the product.
    Specifies whether the ingredient is an active ingredient.
    A subdivision of a product.
    A description of the types of names an applicant assigns to a product.

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