Foley Partner David Rosen was quoted in an article that appeared in FDA Week on June 24, 2010 titled “OIG, Stakeholders Urge FDA To Clamp Down On Foreign Clinical Trials.” Rosen discusses criticisms directed towards the Food and Drug Administration (FDA) by lawmakers and drug safety advocates for what they view as lackluster oversight of clinical trials conducted abroad. He states that data collected during pivotal trials is likely to come under scrutiny by the FDA, adding that the majority of companies are working hard to ensure that data generated outside the U.S. is of very high quality.
