For FDA, An NME Advisory Committee Extravaganza?
Executive Summary
The beginning of 2008 could mark a significant shift in the way FDA reviews applications. A provision included in the FDA Amendments Act specifies that FDA shall either refer each NME to an advisory committee for review or provide in the action letter a summary of the reasons why it did not refer the product - and there is some indication that the agency is taking the former route.
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