Updated with Registration Information: SBIA | FDA Workshop of The Role of Phytosterols in PNALD/IFALD

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Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance WORKSHOP FDA Workshop of The Role of Phytosterols in PNALD/IFALD May 6, 2022 9:30 AM - 4:30 PM ET Register 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.  TOPICS COVERED 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 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)   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 The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training Watch Learning Library Recordings on YouTube Subscribe to CDER SBIA Email Updates Follow on LinkedIn Follow on Twitter

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