Comment from Jeff Walentowski
AnonymousSupportIndividual
Summary: The commenter provides specific feedback on the proposed framework, advocating for the use of Activities of Daily Living (ADLs) as primary metrics and the inclusion of more diverse, impaired patient populations in trials. They also suggest clarifying guidelines for small patient populations and addressing potential inconsistencies in IRB reviews across multi-site trials.
Comments for Docket # FDA-2026-D-1256 "Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause". I am submitting late because the link was taken down before the midnight deadline on Aril 27.