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.
You may also be interested in...
Breakthrough In Two Pages: FDA Offers Preliminary Advice
Agency now allows sponsors of potential breakthrough therapies to request preliminary advice, but sponsors may not necessarily want to use it.
PDUFA Negotiations: Early Communications, Breakthrough Still On Docket
FDA and industry also talking about improvements to combination product review process as part of user fee program renewal.
Breakthrough Requests: FDA Adds Quick Screen To Pare Workload
Hope is to quickly reject obviously inadequate designation requests, but few meet criteria for dismissal so far.