Best Practices for Communication between FDA and Applicants during the NDA Review Cycle: A PhRMA White Paper

Abstract

The process of development, manufacturing, registration, distribution, and postmarketing support of drug and biologic products includes the need for clear, active, and ongoing communication between the sponsor/applicant and the Food and Drug Administration (FDA). Such communication occurs in written and spoken form, involving multiple media (including letters, secure e-mail, fax, face-to-face meetings, and teleconferences). Personnel in PhRMA member companies and FDA recognize the importance and challenges of communication. FDA’s attention to a number of key principles of communication is illustrated in the guidance document Good Review Management Principles and Practices for PDUFA Products. In this white paper, members of PhRMA’s Best Practices Working Group have summarized key information on communication from the guidance document, proposed expectations for communications to facilitate a shared understanding between FDA and applicant about a communication strategy during review of a New Drug Application (NDA) or Biologics License Application (BLA), and drafted some basic principles for companies to adopt to help foster constructive, professional, and efficient communication with FDA on Prescription Drug User Fee Act (PDUFA) products. Dialogue with FDA and other stakeholders about these principles and proposals is suggested as the logical next step in discussion of best practices for communication.