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Fixed-combination drugs: precedent(s) for waiver from requirement to demonstrate each component contributes to claimed effects of fixed-combination drug

  • 1.  Fixed-combination drugs: precedent(s) for waiver from requirement to demonstrate each component contributes to claimed effects of fixed-combination drug

    This message was posted by a user wishing to remain anonymous
    Posted 09-Mar-2022 11:31
    This message was posted by a user wishing to remain anonymous

    Are there precedents in the public domain for waivers from the requirement to demonstrate that each component of a fixed-combination drug makes a contribution to the claimed effects of the fixed combination [21 CFR 300.50(a)]?  I am particularly interested in precedent(s) that do not involve the risk of resistance to component drugs as rationale for a waiver.

    Thank you for any direction you can provide...


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