Briefing Document/Book (and Response Documents) (BRD)

A Briefing Document (BRD) is a good communication vehicle to keep a Regulatory Authority abreast of certain issues in a professional manner and can be used to request scientific advice in relation to a proposed drug development pathway. A BRD often formulates different questions with the goal of getting the Regulatory Authority to address the issues. To facilitate this process, the document contains proposed solutions for the presented questions and appropriate background information.

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