FDA Trial Data Disclosure Could Impede Device Innovation

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The FDA proposal to divulge clinical trial data as a means of speeding diagnostics and therapeutics to market continues to draw fire, and Boston Scientific (Natick, Massachusetts) said in an Aug. 5 statement that the release of trade secrets and confidential commercial information could “impede global innovation in the medical device space.” The widespread resistance to the proposal seems to suggest that investors might pull back from med tech if the agency follows through, and thus reduce research and development into devices and diagnostics, a trend that would run precisely counter to the agency’s goal

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