COPD Post-Market Requirements: Cardiovascular Safety Could Evolve to Comparative Trials
This article was originally published in RPM Report
Executive Summary
Forest's aclidinium breezed through an advisory committee review with three strong votes in favor of approval. The FDA panel, however, also included an interesting call for more head-to-head trials in COPD from the outgoing panel chair. That may impact Forest's Phase IV work--but more importantly it may be a sign of the future expectations for other sponsors in the active COPD development area.
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