FDA Hosts ICH M15 Webinar to Clarify Model-Informed Drug Development Submission Standards on October 29

Regulatory affairs leads preparing MIDD packages for FDA submission now have a structured opportunity to resolve documentation and framework questions before they reach the review desk. The FDA has scheduled a live stakeholder webinar on October 29, 2026 (8:30–10:00 a.m. ET) to walk through the final ICH M15 guideline, "General Principles for Model-Informed Drug Development," adopted by the International Council for Harmonisation in February 2026 and implemented by FDA in June 2026.

The guideline establishes a harmonized assessment framework for MIDD evidence, covering planning, model evaluation, and documentation standards, along with a unified terminology set intended to reduce inconsistency across submissions and regulatory interactions. For teams already mid-program, the terminology alignment alone carries practical weight: divergence between sponsor and agency vocabulary has historically generated avoidable information requests during review cycles.

The webinar is structured in two parts. Pre-recorded presentations covering core M15 concepts will be made available ahead of the live session; the October 29 event itself is designed for direct engagement with FDA scientists in the MIDD community. The agency has framed one explicit objective as gathering feedback to inform the development of additional training materials and case examples, signaling that M15 implementation guidance is still being built out.

A case example will be used to illustrate how the guideline's general principles apply in practice, which should be of direct use to regulatory leads drafting model-informed sections of INDs and NDAs. Common application questions will also be addressed during the live session. No registration is required, and there is no attendance fee; questions can be submitted in advance to [email protected].

Teams with active MIDD programs should treat the pre-recorded materials, once released, as a baseline alignment check against current internal documentation practices before the October 29 session.

Source: FDA "What's New: Drugs" RSS Feed via fda.gov, October 2, 2026.