PDUFA Negotiations: Early Communications, Breakthrough Still On Docket
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA and industry also talking about improvements to combination product review process as part of user fee program renewal.
You may also be interested in...
FDA's Breakthrough Workload Will Be Eased By Hiring Reviewers With PDUFA VI Funds
User fees won't support dedicated staff, but rather FTEs that will work on the popular program as needed.
Sponsors, FDA Reviewers To Get More Flexibility Under New User Fee Program
Next iteration of PDUFA will feature new communication plans that allow FDA and sponsors to drop mid-review meetings if desired.
FDA's Breakthrough Bar May Be Set Too Low, Jenkins Says
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.