How to Submit an FDA Briefing Document

A briefing document is a report sent to the Food and Drug Administration (FDA) that outlines a product's background, information to date and rationale for future development. The briefing document is submitted as part of an information packet for a meeting with the regulatory agency. It is a request for scientific advice and also guides the flow of a meeting with the FDA.

Instructions

• 1

  Develop a timeline by working backwards based upon when you would like to meet with the FDA. The FDA will generally schedule a meeting approximately 60 days after the request is received. You will be required to submit the briefing document 30 days prior to the meeting date.

• 2

  Submit a meeting request to the FDA, which informs the FDA of questions up for discussion and whom you believe should attend from the FDA. Each question should contain a brief background to provide context, if necessary for understanding of the question.

• 3

  Establish the strategy of the briefing document and develop the context and background information around each of the questions. Ensure the document is clear, well-structured and provides an accurate and complete account of a product's status.

• 4

  Submit the briefing document and information package to the FDA and distribute the material to all meeting attendees.