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

In March 2015, FDA issued a draft guidance providing recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological drug products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). This guidance does not apply to abbreviated new drug applications, applications for biosimilar biological products, or submissions for medical devices.

This draft guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings. These GMMPs are intended to provide consistent procedures that will promote well-managed meetings and to ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately.

This draft guidance revises the guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants issued in May 2009. After it has been finalized, this guidance will replace the May 2009 guidance. Significant changes from the 2009 version include:

• Addition of the written response meeting format for pre-investigational new drug application (pre-IND) and Type C meetings
• Designation of a post-action meeting requested within 3 months after an FDA regulatory action other than approval as a Type A meeting
• Designation of a post-action meeting requested 3 or more months after an FDA regulatory action other than approval as a Type B meeting
• Designation of a meeting regarding risk evaluation and mitigation strategies (REMS) or postmarketing requirements that occur outside the context of the review of a marketing application as a Type B meeting
• Inclusion of a meeting package in Type A meeting requests
• Designation of meetings to discuss the overall development program for products granted breakthrough therapy designation status as a Type B meeting

Contact RPI for assistance with FDA interactions, including meeting preparation and representation at FDA meetings.