The US Food and Drug Administration (FDA) finalised its guidance for the content and format of the clinical pharmacology section for human medicine and biological product labelling. The guidance described the data required for the clinical pharmacology section of the labelling for drugs, biologics and generics for new submissions and amendments. The final version of the guidance is much the same as the previous draft, although the document has been significantly rewritten and contains some new information. One new section clarifies that companies do not need to submit a labelling supplement just to make a minor formatting change, i.e., it is not a change driven by a regulatory requirement or a safety issue. Minor formatting changes should be included in the product’s next annual report.
To access the guidance, please click here.