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The Case Of The Suspect Spreadsheet: Semler Sues US FDA Over Data Integrity Concerns

Executive Summary

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.'

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CRO Does Not Have Same Rights As Sponsor, Court Says In Tossing Semler Suit Against US FDA

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