PDUFA Negotiations: Early Communications, Breakthrough Still On Docket
This article was originally published in The Pink Sheet Daily
FDA and industry also talking about improvements to combination product review process as part of user fee program renewal.
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User fees won't support dedicated staff, but rather FTEs that will work on the popular program as needed.
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.