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Breakthroughs for Patients, CMC Regulatory Flexibility

This article was originally published in The Gold Sheet

Executive Summary

By compressing clinical timelines, a FDASIA-mandated “breakthrough therapy” application process is pressuring FDA and industry to complete CMC reviews much more quickly. While FDA is emphasizing starting earlier and working harder, industry is talking more about the possibility of deferring some CMC activities post-submission or post-approval.

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