Day: February 12, 2026

Artificial intelligence (AI) and advanced modeling are reshaping how drugs and biologics are developed, reviewed, and regulated worldwide. In late 2024 and early 2025, the FDA released draft guidance on AI use in regulatory submissions, while the International Council for Harmonization (ICH) finalized its M15 guideline on model-informed drug development (MIDD). Together, these documents signal … Read more

What if regulatory decisions reflected not just clinical endpoints, but what patients truly value? What if benefit–risk assessments explicitly accounted for patients’ willingness to accept uncertainty, risk, or trade-offs? The FDA’s adoption of ICH E22 signals its perspective on using patient preferences for regulatory decisions by formalizing how structured patient preference data can be designed, … Read more