Breakthroughs for Patients, CMC Regulatory Flexibility

30 Jan 2014

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.

By reducing the time from first-in-human studies to product launch, normally seven to 10 years, to just three to five...