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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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.'
Data integrity spotlight expands beyond cGMP as FDA finds Semler manipulated study subject samples in bioequivalence studies conducted at its Bangalore facility.
Comments on September draft guidance seek more attention to differences between the two types of data sources; pharma firms said they may not always have access to all the information the US FDA wants to see about a particular data source, and they seek additional flexibility on validation.