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Electronic Lot Distribution Reports Are More Complex Than You Think


Electronic Lot Distribution Reports Are More Complex Than You Think

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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 Application (BLA). Some companies must submit their first reports in Structured Product Labeling (SPL) format as early as this month, and many are finding […]

3 Options for Managing Biologic Lot Distribution Reports (LDR)

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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 for BLA holders to know that a new FDA LDR submission format will soon be required to help make the data contained in […]