FDA - Preparation Tips For Meetings With The FDA

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If you have upcoming meetings with the FDA, or are looking for ways to be more effective during the meeting, then this slide deck is a must read, Strategies to Prepare for Meetings with the FDA by Kim Colangelo Associate Director for Regulatory Affairs Office of New Drugs, CDER, FDA (circa 2006). In summary, she highlights these 3 things:

• Meetings Are a Critical Component of the Way We (Industry and FDA) Do Business
• Extensive Framework Around Meeting Process and Procedures Enhance Predictability
• Efficient Use of Meetings Facilitates Our Shared Public Health Goal

Related Posts: FDA Guidance - FDA and Sponsor-Applicant Meetings

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FDA Guidance - FDA and Sponsor-Applicant Meetings

• Recommended FDA cGMP online training courses, programs, and classes offered by SkillsPlus International Inc.

Updated October 24, 2022

The original link broke.

There are many FDA guidance documents intended for meetings between the FDA and Sponsors or Applicants.

You can find them by searching the FDA website:

Search for FDA Guidance Documents - FDA.gov

---  the original post follows below  ---

This FDA guidance, Guidance for Industry Formal Meetings Between the FDA and Sponsors or Applicants, 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. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant following the request procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference, or videoconference). 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 supersedes the guidance for industry Formal Meetings With Sponsors and Applicants for PDUFA Products published February 2000. The 2000 guidance implemented section 119(a) of the Food and Drug Administration Modernization Act of 1997, and reflected a unified approach to all formal multidisciplinary meetings between sponsors or applicants and the FDA. 

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