When FDA published its draft guidance on AI in drug development in January 2025, many regulatory teams assumed it applied broadly to all AI-assisted document work. It does not. The guidance explicitly excludes AI used for "drafting or writing a regulatory submission" when that drafting does not itself affect patient safety, drug quality, or study reliability. The scope covers AI models that produce information or data to support regulatory decisions about safety, effectiveness, or quality, such as AI that stratifies patients for safety monitoring or performs automated quality assessments. For in-scope AI, FDA recommends a seven-step credibility framework including defining context of use, assessing model risk, and documenting credibility evidence. ICH E6(R3), effective in 2025, reinforces that sponsors retain ultimate responsibility for AI-generated content and must maintain data governance and computerized system controls proportionate to risk. Part 11 applies when AI tools create regulated records, though it predates modern AI and does not address LLMs directly. The FDA and EMA's January 2026 joint principles emphasize that AI does not substitute for human accountability.