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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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FDA “Flexibility” Presages Good Climate in 2012 for Approval Decisions, Shortage Situations

As FDA girds for the Capitol Hill phase of the user fee reauthorization push in 2012, the agency is projecting an image as a flexible problem-solver. FDA’s underlying message: the agency has sufficient authority and does not need tinkering with the legislative mandate. From the drug industry’s perspective, a continued stress on flexibility through the first nine months of the year could create a favorable climate for application reviews and for resolving lingering manufacturing issues.

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