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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Top Stories of 2014
Readers of “The Gold Sheet” focused more on articles about data integrity than any other topic last year, which is a big reason why data integrity was the No. 1 story of 2014. A number of other highly read articles last year focused on additional topics that were also among the top stories in pharmaceutical manufacturing quality last year.