Guides & Guidelines

IntroductionTransthyretinexternal link, opens in a new tab amyloid cardiomyopathyexternal link, opens in a new tab (ATTR-CM) is a progressive disease that causes…

Amyloidosis is a systemic disorder characterized by the extracellular deposition of amyloid fibrils in various tissues, with the potential for cardiac involvement.…

Study Questions:What is the prognostic importance of an increase in N-terminal pro–B-type natriuretic peptide (NT-proBNP) and outpatient diuretic intensification (…

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and…

Amyloidosis is a protein folding disease that causes organ injuries and even death. In humans, 42 proteins are now known to cause amyloidosis. Some proteins become…

FDA is developing a series of four methodological patient-focused drug development (PFDD) guidance documents to address, in a stepwise manner, how stakeholders can…

ObjectivesThis study has been conducted to investigate the non-invasive diagnostic journey of patients with a transthyretin amyloid cardiomyopathy (aTTR-CM) in…

Cardiac amyloidosis is a type of amyloidosis that deserves special attention as organ involvement significantly worsens the prognosis. Cardiac amyloidosis can be…