FDA proposal on overseas device trials gets industry pushback

06/4/2013 | MassDevice.com (Boston)

An FDA proposed rule that would subject medical-device trials conducted outside the U.S. to additional ethical review has drawn industry concerns. In a letter to the FDA, AdvaMed said some of the plans may conflict with policies in other countries and urged the FDA to wait for development of "a harmonized, international medical device and IVD GCP guideline."

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MassDevice.com (Boston)

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