Toward a New Regulatory Paradigm for Lipid Emulsions for Parenteral Nutrition

Time

Tue, Jun 25 11:45AM
T 01

Title

Toward a New Regulatory Paradigm for Lipid Emulsions for Parenteral Nutrition

Abstract Summary

The regulatory history of parenteral nutrition lipid emulsions in the US has been reviewed by use of publicly available US government databases. The technical basis for current regulatory policy was explored through analysis of the Food, Drug & Cosmetic Act, and the Code of Federal Regulations, as well as the transcript of an FDA public workshop. Position papers published by professional associations and review articles published by nutrition experts were also examined.

Poster Presenter

Edward Tabor
MD,
Vice President, Regulatory Affairs North America,
Fresenius Kabi USA
United States

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