The Food and Drug Administration (FDA) Center for Drug Evaluation and Research in co-sponsorship with the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) is holding a 1-day public workshop entitled "Clinical Trial Design for Intravenous (IV) Fat Emulsion Products." This workshop will provide a forum to discuss trial design of clinical trials intended to support registration of IV fat emulsion products. Stakeholders, including industry sponsors, academia, patients receiving parenteral nutrition, and the FDA, will be engaged to address challenging issues related to selection of endpoints and assessment methodologies in registration trials. Trial design strategies and possible candidates for endpoints will be explored.
There is no fee to attend the public workshop, but attendees must register before October 22, 2013.
Space is limited, and registration will be on a first-come, first-served basis.
Additional location information for attendees can be found on the FDA Website.