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Postmarket Commitments Increase

Postmarket Commitments Increase

FDA’s approval of Amgen’s osteoporosis treatment, Prolia (denosumab), came with strings attached.  Postmarket surveillance requirements – including Phase IV trials and studies – are increasingly part of the FDA approval pathway in the 21st century.  There are a number of reasons for this, including … Continue reading at ComplianceZen.com →