Manan Shah

Manan Shah is Senior Manager, Regulatory Affairs, G&L Healthcare Advisors, US.

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    Overview of importation
    strategy from an
    FDA perspective
    – PLAIR vs FTZ


    In the current landscape, pharmaceuticals and biologics are manufactured at global current good manufacturing practice facilities for distribution in the US market. The importation of these products is a crucial process, as it ensures that patients can access these products in a timely fashion upon approval of applications to health ...