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Medical device makers take exception to the structure of FDA's recommendation that overseas clinical trials get an extra layer of ethical review. The medical device industry has a few qualms with the FDA's latest proposal to add a layer of ethical review to clinical studies conducted overseas. Medtech industry lobbying group AdvaMed commended the FDA and generally lauded the agency's efforts to promote principals of "Good Clinical Practice" in international clinical trials, but warned that certain of the FDA's proposals may butt heads with rules governing medical information in other countries. AdvaMed requested that the FDA delay any finalization of overseas trials rules until "a harmonized, international medical device and IVD GCP guideline has been established and adopted," according to a response the organization submitted to the FDA.
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Medical device makers take exception to the structure of FDA's recommendation that overseas clinical trials get an extra layer of ethical review. The medical device industry has a few qualms with the FDA's latest proposal to add a layer of ethical review to clinical studies conducted overseas. Medtech industry lobbying group AdvaMed commended the FDA and generally lauded the agency's efforts to promote principals of "Good Clinical Practice" in international clinical trials, but warned that certain of the FDA's proposals may butt heads with rules governing medical information in other countries. AdvaMed requested that the FDA delay any finalization of overseas trials rules until "a harmonized, international medical device and IVD GCP guideline has been established and adopted," according to a response the organization submitted to the FDA.
Help employers find you! Check out all the jobs and post your resume.
