FOR IMMEDIATE RELEASE
October 28, 2013
Fat emulsions are used as part of intravenous or parenteral nutrition for patients who are unable to take nutrients via their GI tract, usually because of certain illnesses or recent surgery. Fats are used by the body for energy and to form substances needed for normal body functions.
There are currently only limited types of intravenous fat emulsion (IVFE) products in the US, whereas around the world, many other types are available, often with better safety profiles.. In addition, healthcare providers in the United States have been struggling with a shortage of intravenous fat emulsion products, since 2009.
The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), in cosponsorship with the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, is holding a one-day public workshop entitled “Clinical Trial Design for Intravenous Fat Emulsion Products.”
This workshop will provide a forum to discuss the key issues in clinical trial design for the evaluation and approval of new intravenous fat emulsions products for the US market.
“As the need for new fat emulsion products increases, it is important that we have an effective system for testing of these new products for patients in our country,” said Peggi Guenter, PhD, RN, Senior Director of Clinical Practice, Advocacy, and Research Affairs for A.S.P.E.N.
Stakeholders, including industry sponsors, academia, patients receiving parenteral nutrition, and FDA, will discuss challenging issues related to selection of endpoints and assessment methodologies in registration trials. Trial design strategies and possible candidates for endpoints will be explored. An article on the proceedings will be published in one of the A.S.P.E.N. journals in the near future.
WHEN: Tuesday, Oct. 29, 2013, from 8 a.m. to 5 p.m. (EST).
WHERE: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002.
Members of the media wishing to attend the workshop or to view it live online, may contact Stephen King, Center for Drug Evaluation and Research, Food and Drug Administration, at 301-796-3595 or at [email protected].
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The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is dedicated to improving patient care by advancing the science and practice of nutrition support therapy and metabolism. Founded in 1976, A.S.P.E.N. is an interdisciplinary organization whose members are involved in the provision of clinical nutrition therapies, including parenteral and enteral nutrition. With more than 5,500 members from around the world, A.S.P.E.N. is a community of dietitians, nurses, nurse practitioners, pharmacists, physicians, scientists, students and other health professionals from every facet of nutrition support clinical practice, research and education. For more information about A.S.P.E.N., please visit www.nutritioncare.org.