IXA Information Exchange Meeting with the FDA

Dear Members,

The International Xenotransplantation Association (IXA) Council will be holding an information exchange meeting with representatives of the Federal Drug Administration (FDA) during the upcoming American Transplant Congress in Boston in June 2016. The purpose of the meeting is to update the FDA on the latest developments in xenotransplantation and to learn about the FDA approval procedure for xenotransplantation clinical trials, followed by a discussion to convey the key issues to the FDA including the possibility of modifying the current guidelines.

We would like to ensure that members have their say in this process, so we ask that if you have any specific questions or suggestions for changes to the guidelines (attached), please send them to IXA Secretariat at This email address is being protected from spambots. You need JavaScript enabled to view it. by April 30, 2016.

Sincerely,

 
Peter Cowan
IXA President 
  Muhammad Mohiuddin
IXA Communications Taskforce Chair

  FDA CVM Guidance for Industry #187 (2009, updated 2015)

  FDA Guidance for Xenotransplantation Products (2003)