FDA warns Pfizer about trial monitoring
In a warning letter published on the FDA’s website yesterday, the agency said the US drug major had “failed to ensure proper monitoring” that the trial was being conducted in accordance with the approved protocol.
The agency also said that overdosing was “neither recognized nor reported to study monitors in a timely manner.”
According to the Associated Press, Pfizer said that the observations were made during a the trial of the antipsychotic Geodon that took place in July 2009, which in itself was a follow-up of an investigation that took place in 2006.
Company spokeswoman Kristen Neese said: "Pfizer has communicated with the FDA about our conduct of clinical trials and, over the next two weeks, will provide an outline of new and existing processes for preventing similar issues.”
