ASTM WK72293

    New Guide for Standard Guide for Definition of Combination Products (Drug / Device / Biologic Combinations)

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    Developed by Subcommittee: E55.03 | Committee E55 | Contact Staff Manager



    WK72293

    1. Scope

    This Standard defines and gives examples of Combination Product presentations. This could include presentations such as combinations of Drug and Device and/or Biologics. The standard will define types of combination products at a high level.


    Keywords

    Combination Product; Combo Product; Mode of Action; PMOA; Biologic Combinations

    Rationale

    Currently, there are a variety of terminologies and definitions within different jurisdictions. This Standard Guide will serve as the global reference for Combination Products and related topics.

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    03-16-2020

    Technical Contact:
    Manfred Maeder

    Status:
    Draft Under Development