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HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface


HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface

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Many in the medical device industry make plans to use the free FDA Web Interface based on the assumption that they don’t have enough products to warrant the use of Structured Product Labeling (SPL) for their GUDID submissions. The decision would seem to make sense for a company with 100 or fewer UDI device records […]

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 […]