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Feigal: need to integrate "least burdensome" more effectively

This article was originally published in Clinica

Executive Summary

The US FDA still has a long way to go before it has succeeded getting the message across to product reviewers about the importance of choosing the least burdensome regulatory path for a premarket approval (PMA) application. That is one of the initial findings of a survey conducted recently by the agency and released at this year's annual meeting of AdvaMed, the Advanced Medical Technology Association (see Clinica No 952, p 11).





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