ARC's library contains publications and articles published in peer reviewed journals on the latest research that ARC has been engaged in.
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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 ARC is requesting that the FDA issue a draft guidance incorporating the information in this externally-developed draft guidance.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
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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.