Myriad Assistant
Ask about a regulatory change in plain language. Each answer links to the official text it is based on, so you can check it yourself. We do not train models on your data.
Does this change our model documentation for the Phase II submission?
No new duty, it is guidance, issued jointly with the EMA. It aligns the credibility-assessment expectations across both agencies, so one model dossier can serve both filings.
FDA-EMA GMLP principles, Jan 2026
















