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Lot Distribution Reports for Biologics

  • Electronic Lot Distribution Reports Are More Complex Than You Think

    Electronic Lot Distribution Reports Are More Complex Than You Think

    New FDA regulations for submitting electronic Lot Distribution Reports (LDRs) went into effect June 10, 2015. They apply to all companies that market products in the U.S. under a Biologics License...

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  • LDR Readiness Kit

    LDR Readiness Kit

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  • 3 Options for Managing Biologic Lot Distribution Reports (LDR)

    3 Options for Managing Biologic Lot Distribution Reports (LDR)

    It is not new that the FDA requires the submission of Lot Distribution Reports (LDRs) for all products marketed in the U.S. under a Biologics License Application (BLA). However, it is important...

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