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Open Season at Open Sessions: Benlysta May Presage Resurgence of Public Pressure on FDA Committees

This article was originally published in RPM Report

Executive Summary

FDA would be wise to prepare for a new round of active, emotive open public sessions after the impact of the public testimony at the Benlysta lupus drug review on November 16. It’s been a long-time since a public session has had such a direct impact on creating a pro-approval atmosphere at a committee meeting.

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