Wednesday, November 10, 2010

FDA should help monitor overseas clinical trials

In a recent article at Outsourcing Pharma, ACRO Vice President called for more oversight from the FDA and EMA over the clinical trials in developing countries. John Lewis is calling for a $17 million increase to the budget for the FDA's Office of International Programs. This comes just days after a report called for more of the FDA’s international offices to ensure the quality of drug manufacturing.

Should the FDA contribute more to monitoring clinical trial sites around the globe? As an international enterprise that affects all around the globe, how can we make sure monitoring the quality of clinical trials is the same in the US as it is in developing countries?




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