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HHS CLINICAL TRIAL DATABANK WOULD EXEMPT INDUSTRY FROM DISCLOSURES INTERFERING WITH ENROLLMENT UNDER DODD AMENDMENT; COMPOUNDING ADDED TO FDA REFORM BILL

Executive Summary

Companies would not be required to supply information relating to a clinical trial to an HHS database if the company can certify that "the disclosure of such information would substantially interfere with the timely enrollment of subjects in the investigation," according to language incorporated into the Senate Labor and Human Resources Committee FDA reform bill (S 830).

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