Drugs · Sep 17, 2025

Ralph A. DeFronzo, M.D.

2 extracted findings

FDA source excerpt, selected passage

You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].

Findings and supporting evidence

Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.

Selected FDA passages, not the complete letter.

You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].

You failed to promptly report all changes in research activity to the Institutional Review Board (IRB) [21 CFR 312.66].

As cited in this historical letter, not a statement of current regulatory requirements.

Explore Botable’s work in Pharmaceuticals.

For regulated teams

Botable builds and runs a custom AI layer around the software you already use, so your team can do the job you hired them for.