Module 12 Presentations

26/01/2024

US Regulatory Requirement for Labeling

 In a New Drug Application or Biological License Application you will submit draft labeling in a variety of forms. – One of those is as Structure Product Labeling (SPL). – The label is written per the Physician’s Labeling Rule (PLR) but exchanged as SPL.  All subsequent labeling (final and any supplements that include label changes) will also be submitted with SPL

The Organisation for Professionals in Regulatory Affairs

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What the xml looks like:

You will most likely NEVER have to read or write this!

The Organisation for Professionals in Regulatory Affairs

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