---

---

---

The registration link above will also be used for viewing the live workshop

Visit CDER Small Business and Industry Assistance Page

Agenda

ABOUT THIS WORKSHOP

Parenteral nutrition-associated liver disease (PNALD)/ intestinal failure-associated liver disease (IFALD) can occur in patients who require parenteral nutrition for more than two weeks, and the incidence increases with longer duration of treatment. PNALD/IFALD can result in permanent liver injury, and sometimes results in liver transplant or death. Although PNALD/IFALD has many risk factors, the phytosterol content of intravenous lipid emulsions (ILEs) used as part of total parenteral nutrition is a modifiable risk factor. In the last six years, FDA approved ILEs with lower or no phytosterol content.

This scientific workshop will discuss:

• The changing epidemiology of PNALD/IFALD over the last decade
• Strategies for managing PNALD/IFALD
• The role of phytosterols in the disease process
• Potential next steps for mitigating the risk of PNALD/IFALD

INTENDED AUDIENCE

• Neonatologists, pediatric gastroenterologists and hepatologists, pediatric surgeons, adult gastroenterologists and hepatologists, PharmDs with a nutrition focus, nutritionists
• Manufacturers of intravenous lipid emulsions
• Researchers working on parenteral nutrition-associated liver disease/ intestinal failure-associated liver disease
• Foreign regulators

FDA RESOURCES

FDA-approved product labeling for the marketed intravenous lipid emulsions:

• Intralipid (soybean oil)
• Nutrilipid (soybean oil)
• Clinolipid (olive oil, soybean oil)
• SMOFlipid (soybean oil, medium-chain triglycerides [MCTs], olive oil, and fish oil)
• Omegaven (fish oil triglycerides)