There is a very brief description of the NDA Reviewer's Guide in the eCTD Technical Conformance Guide (March 2022). I don't know of another guidance on content and format. My approach for this Guide is to provide a description in outline form of the characteristics of the submission, particularly if there is something that is unusual about the submission content or if something that is usually expected is missing. For example, if FDA has agreed to not having a separate ISE or ISS document in Module 5, that agreement would be included and explain why Module 2 summaries contain all of the requested information.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 13-Oct-2022 16:34
From: Anonymous Member
Subject: NDA/BLA Reviewer Guide
This message was posted by a user wishing to remain anonymous
Dear Colleagues,
Is there available guidance regarding how to prepare an NDA/BLA reviewer guide? I have seen a reasonably wide range of approaches to developing this tool. Some appear to have greater utility than others.
Is a reviewer guide required for NDAs/BLAs?
Thank you in advance for your guidance.