Comment from Anonymous
AnonymousOtherIndividual
Summary: The commenter is a regulatory medical writing lead for a pharmaceutical sponsor seeking specific clarification on the FDA's stance on using AI for authoring various regulatory documents. They are asking for guidance on whether AI-generated content is permissible when human-oversight is maintained and how such usage should be documented.
I am regulatory medical writing lead for a Sponsor, and am in urgent need of some FDA guidance regarding AI use when authoring regulatory documents, e.g. CSPs, ICFs, CSRs, briefing books, etc. Specifically, (a): is AI use allowed, as long as a human takes ownership for any outputs that are used in final documents? (b) if AI contributed materially, not only for spellcheck/grammar etc, but also for analysis of aggregated patient data (e.g. for a CSR), or if AI helped to generate novel ideas/conclusions that are then used as arguments in a briefing book (while a human takes final responsibility and reviews the AI-generated output), are those AI use cases allowed, and does the AI use in that scenario need to be documented/submitted to FDA, and if so, how? (Specifically for eCTD documents, as well as for other materials like briefing books)? Many thanks