eCTD Reviewers Guide Helpful but Not Required

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In various presentations in the past, FDA speakers have mentioned the concept of an eCTD reviewers’ guide. A reviewers’ guide is not required, but can be helpful in providing a high level overview of an application.  Recently, I asked the FDA’s Office of Business Informatics (OBI) to share some thoughts about what would be useful for sponsors to provide in a user guide. They provided some guidelines as follows:

  • If a reviewers’ guide is provided, it is usually a separate document in the cover letter section.
  • Provide a high level summary of what is provided in modules 1 through 5, including links if possible.
  • For module 5, references the pivotal studies, ISS, ISE and explain how data is being submitted (SDTM or non-SDTM)
  • Discuss any documents which may be specific to the particular application being submitted (e.g., abuse potential, pulmonary white paper, etc.) which may not be common documents in all applications.

The reviewers’ guide usually consists of three to 10 pages, but there have been some that are up to 30 pages.

Author: GS

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