U.S. Food and Drug Administration
Protecting and Promoting Your Health
Submitting a Meeting Request (Cont.)
Information to include in a meeting request (Cont.):
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A brief statement of the purpose and objectives of the meeting
- Brief background of the issues
- A brief summary of completed or planned studies and clinical trials
- Data that the sponsor or applicant intends to discuss at the meeting
- The general nature of the critical questions to be asked
- Where the meeting fits in overall development plans
- Provide enough information to facilitate understanding of the issues
- A proposed agenda
- A list of proposed questions, grouped by discipline
- A list of all individuals who will attend the requested meeting
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