FDA Warns Pfizer for Failures to Monitor Drug Trial

Pfizer failed to properly monitor an investigational drug trial — a repeat violation — which led to widespread overdosing of subjects, the FDA says. Study monitors failed to ensure that the trial was conducted according to the investigational plan, and investigators weren’t kept informed of new observations reported to the sponsor, particularly those involving safe use or adverse events, according to an April 9 warning letter posted online Tuesday.
Drug Industry Daily