(Total Views: 484)
Posted On: 09/15/2025 12:26:41 PM
Post# of 157025
Wasn't sure what a briefing book was or what purpose it served. Here's an hour presentation on it for folks (like me!) who weren't particularly familiar with the concept: https://www.youtube.com/watch?v=zPTICeZtxcs&a...terionEdge
Or the TLDW:
Purpose of an FDA Briefing Book
Inform FDA reviewers:
The primary goal is to provide the FDA with necessary background information to understand the sponsor's product and the specific issues to be discussed.
Facilitate discussion:
It serves as a tool for the FDA to engage in conversation and facilitate effective communication, helping to resolve concerns and improve product development.
Establish a positive impression:
A well-written briefing book demonstrates professionalism and thoroughness to the FDA, which can influence the perception of the sponsor's capabilities.
Key Components of a Briefing Book
Introduction: An overview of the product and its development.
Nonclinical data: Relevant nonclinical (pre-clinical) study results.
Clinical data : Information on any available clinical data.
Regulatory strategy: The sponsor's plans and approach for regulatory submission.
Questions and position statement: A list of specific questions the sponsor wants to address, along with a statement of their position, supported by the data in the book.
Or the TLDW:
Purpose of an FDA Briefing Book
Inform FDA reviewers:
The primary goal is to provide the FDA with necessary background information to understand the sponsor's product and the specific issues to be discussed.
Facilitate discussion:
It serves as a tool for the FDA to engage in conversation and facilitate effective communication, helping to resolve concerns and improve product development.
Establish a positive impression:
A well-written briefing book demonstrates professionalism and thoroughness to the FDA, which can influence the perception of the sponsor's capabilities.
Key Components of a Briefing Book
Introduction: An overview of the product and its development.
Nonclinical data: Relevant nonclinical (pre-clinical) study results.
Clinical data : Information on any available clinical data.
Regulatory strategy: The sponsor's plans and approach for regulatory submission.
Questions and position statement: A list of specific questions the sponsor wants to address, along with a statement of their position, supported by the data in the book.
(9)
(0)
