AI and the Regulatory Roadmap: Why Structured Submissions Win

AI is changing the rules of play for regulatory submissions. With FDA eSTAR now mandatory for most filings, sponsors must adopt structured formats that are machine-readable by design. The FDA is actively deploying AI tools to assist in reviewing structured data and has issued guidance on AI model credibility and context of use. Certain elements, like the Software Bill of Materials (SBOM), are already required in machine-readable formats. .