On May 29th this year, the FDA opened a consultation to obtain information and comments from patients, patient advocates, the scientific community, health professionals, other regulatory and health authorities in the global community, regulated industry, and the general public regarding practical steps and successful approaches to establish a global rare disease clinical trials network.
c4c convened representatives of the European Rare Disease and Paediatric clinical trial communities who developed a shared response to the questions raised by the FDA.
The group includes the European Reference Networks, The European Joint Programme for Rare Diseases, EURORDIS and c4c.
The submission emphasizes the importance of including European initiatives in a global clinical trials network.
Download the submission from the European Networks here: