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PCSK9 Cholesterol Drugs And FDA’s Missing Mandatory Study Authority

This article was originally published in RPM Report

Executive Summary

FDA has some work to do to interpret the Endocrinologic & Metabolic Drugs Advisory Committee’s advice about whether and when LDL-lowering can be treated as a fully valid surrogate endpoint to support approval. The issue would probably be a lot simpler for FDA—and the sponsors of a new class of highly effective LDL-lowering therapies—if FDA had authority to mandate trials for efficacy.



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