Your drug product labeling (aka package insert) may be out of date for a variety of reasons.
These include many less obvious concerns such as pregnancy categories, outdated references, different labeling in other countries, or safety concerns that have been described by other drugs in the same class.
Many factors can affect the information, which should be included in your drug product’s package insert, and several are described in this paper.
It is the obligation of the sponsor to ensure that drug product labeling is compliant (current, complete, comprehensive, correct, and consistent).
It may be time for a critical review of your drug’s package insert. Feel free to download this paper and contact us to learn more.