ARC Publications

 ARC's library contains publications and articles published in peer reviewed journals on the latest research that ARC has been engaged in.


ARC Publications

Click on image to download report.

Guidance for Industry                  AL Amyloidosis                           Developing Drugs for Industry

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. ARC is requesting that the FDA issue a draft guidance incorporating the information in this externally-developed draft guidance.

The Voice of the Patient

Summary report resulting from the first Externally-led Patient Focused Drug Development meeting, a parallel effort to the FDA's Patient focused Drug Development Initiative.

Rationale, Application, and Clinical Qualification for Use of NT-proBNP as a Surrogate End Point in Pivotal Clinical Trials in Patients with AL Amyloidosis

 

 

Submitted to FDA December 2016

Published June 2016

Published October 2015


Articles

Click on image to download article.

Rationale, Application and Clinical Qualification for NT-proBNP as a Surrogate End Point in Pivotal Clinical Trials in Patients with AL Amyloidosis

Published: Leukemia July 2016

Author: G Merlini et al.