Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products

This guidance provides recommendations to sponsors and applicants of Prescription Drug User Fee Act (PDUFA) products on formal meetings with FDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, including principles of good meeting management, procedures for requesting and conducting meetings, meeting types and formats,... The post Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products appeared first on Avance Biosciences .