Resources

A comprehensive report submitted to the FDA in 2016 by ARC. This is a detailed summary of the patient testimony presented at the Patient-Focused Drug Development meeting. This report will serve a critical function in communicating to both FDA review staff and industry the improvements that patients want and hope to see in their daily lives.    

Published: Leukemia, July 2016 | Author: G Merlini et al.

Published: Advances in Therapy, 2015 | Author: I Lousada et al.

Amyloidosis Research Consortium Cardiac Amyloidosis Survey: Results from Patients with AL Amyloidosis and Their Caregivers, was presented at the European Hematology Association (EHA) 22nd Annual Congress from June 22 - 25, 2017 in Madrid, Spain. This poster captures results from 137 AL amyloidosis patients and caregivers to help understand the difficult diagnostic journey and experiences of AL amyloidosis patients.

Developing the guidance involved active participation from all stakeholder groups including patients, medical experts, academics and biopharmaceutical industry representatives. This guidance has been submitted to FDA.