U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Engaging with the FDA During New Drug Development
Formal Meetings with FDA
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Submitting a Meeting Request (Cont.)

Information to include in a meeting request (Cont.):

  1. 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
  2. A proposed agenda
  3. A list of proposed questions, grouped by discipline
  4. A list of all individuals who will attend the requested meeting

"To Do List" with pencil having checked three out of four boxes as completed.
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