US companies make case for FDAMA (FDA Modernization Act) changes
This article was originally published in Clinica
Executive Summary
AdvaMed, the Advanced Medical Technology Association, is to release a critical report on the FDA as it kicks off its campaign urging major revisions to the landmark FDA Modernization Act (FDAMA) of 1997. Among its call is that steps be taken to allow third party reviews of pre-market approvals.