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FDA Prepares For Issues for Treatment of Parenteral Nutrition Associated Liver Disease

This article was originally published in RPM Report

Executive Summary

FDA is planning an advisory committee discussion of the “need for and design of” clinical trials for parenteral nutrition products in the US. The panel was scheduled for October 15 but was cancelled for logistical reasons. The discussion is likely to build on a September public workshop that wrestled with the unique challenges in developing new formulations of vital supportive therapies. In this article, an executive with one of the firms with different parenteral products outside the US (Fresenius/Kabi) outlines the issues raised in the workshop and the reaction of expert panelists.

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