Breakthrough Requests: FDA Adds Quick Screen To Pare Workload
This article was originally published in The Pink Sheet Daily
Hope is to quickly reject obviously inadequate designation requests, but few meet criteria for dismissal so far.
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Next iteration of PDUFA will feature new communication plans that allow FDA and sponsors to drop mid-review meetings if desired.
Office of New Drugs Director recommends that EMA be careful how its sets the bar for its similar PRIME program to ensure it remains meaningful.
CDER Director Woodcock notes breakthrough program often pushes sponsors to modernize production processes.