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Home » Sponsors Urge Exemptions, Consistency in U.S. Proposed Rule on Foreign Data
Sponsors Urge Exemptions, Consistency in U.S. Proposed Rule on Foreign Data
June 6, 2013
The U.S. Food and Drug Administration’s proposed rule on use of overseas clinical trial data for devices should not apply informed consent provisions to in vitro diagnostic studies that use de-identified samples, Roche says in comments to the rule.
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