Salmon Calcitonin and the Challenge of Life-Cycle Regulation
This article was originally published in RPM Report
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 The product is, to put it bluntly, outdated: approved on standards FDA no longer accepts and now commericially irrelevant.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.