Warning Letter — Stephen J. Fallon, Ph.D.
The FDA issued a Warning Letter to Stephen J. Fallon, Ph.D., following an inspection by the Center for Biologics Evaluation and Research (CBER).
Clinical investigators, sponsors of biological product trials, and regulatory compliance teams involved in CBER-regulated studies.
A Warning Letter from CBER indicates significant non-compliance with clinical trial regulations. This may lead to the invalidation of clinical data or administrative actions against the investigator, potentially impacting the timeline or viability of the associated biological product development.
Review clinical investigator oversight protocols and ensure all study documentation and subject safety reporting meet CBER requirements. Conduct internal audits of clinical trial sites to verify compliance with investigational plans.
FDA Warning Letter issued to: Stephen J. Fallon, Ph.D.. 08/27/2026 — Center for Biologics Evaluation and Research (CBER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/stephen-j-fallon-phd-728673-08272026
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