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Breakthroughs for Patients, CMC Regulatory Flexibility

 
• By Bowman Cox

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.

As recent legislation unleashes a torrent of applications for approval of so-called “breakthrough therapies,” the compressed timelines for these reviews are creating opportunities for manufacturers to seek flexibility on quality-related aspects of their submissions.

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