Data Integrity: US FDA Seeks Dismissal Of CRO Semler’s Lawsuit For Lost Business
Contract research organization’s claims that agency improperly relied on a ‘suspect spreadsheet’ in taking actions that damaged its business are barred by sovereign immunity and exceptions to the Federal Tort Claims Act, FDA says; a federal judge in California will hear arguments on motions to dismiss Jan. 15.
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Requiring re-do of Semler bioequivalence studies did not violate the CRO's due process rights, court finds; government has sovereign immunity from 'interference with economic advantage' claims.
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India-based CRO alleges FDA 'annihilated' its business with announcement that sponsors must re-do bioequivalence and bioavailability studies; Semler asserts invalid or falsified study data were never submitted to the agency and FDA's conclusions rest upon a 'suspect spreadsheet' created by a 'rogue employee.'