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).