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How Pragmatic Can Post-Approval Safety Trials Be?

This article was originally published in RPM Report

Executive Summary

The February 23 meeting of the Pulmonary Allergy Drugs Advisory Committee included an interesting colloquy on the potential use of pragmatic trials to answer real-world use and safety questions. FDA Division of Pulmonary, Allergy and Rheumatology Director Badrul Chowdhury began the discussion by questioning a reference to “pragmatic trials” by the Chari of the committee, Jerry Krishnan (University of Illinois Hospital & Health Sciences System).

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