This guidance provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of drug or biological drug products (hereafter 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. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant (hereafter requester(s)) following the request procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference, videoconference, or written response).
This guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings. The general principles in this guidance may be extended to other nonapplication-related meetings with external constituents, insofar as this is possible.
This 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. This draft guidance has been updated in accordance with the Meeting Management Goals section of the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures; Fiscal Years 2013 through 2017. 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