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Salmon Calcitonin and the Challenge of Life-Cycle Regulation

This article was originally published in RPM Report

Executive Summary

An advisory committee is recommending pulling the osteoporosis indication for salmon calcitonin. The product is, to put it bluntly, outdated: approved on standards FDA no longer accepts and now commericially irrelevant. But as a case study in regulating the full life cycle of a medicine, the issues that came up are not to be ignored.


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