Breakthrough Designation Can Be 'Lever' For Manufacturing Evolution, FDA Says
This article was originally published in The Pink Sheet Daily
CDER Director Woodcock notes breakthrough program often pushes sponsors to modernize production processes.
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Agency now allows sponsors of potential breakthrough therapies to request preliminary advice, but sponsors may not necessarily want to use it.
FDA and industry also talking about improvements to combination product review process as part of user fee program renewal.
Hope is to quickly reject obviously inadequate designation requests, but few meet criteria for dismissal so far.