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Clinical Data Fraud Involving CROs Attracting US Justice Department Attention

Executive Summary

Submission of manipulated clinical data to support product approval is a ‘major concern’ for the DoJ, consumer protection branch director Gusav Eyler says, adding that some of the problems relate to outsourcing of trials. Also, DoJ and HHS OIG are using data analytics to identify outliers in prescribing and reimbursement claims.

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Data Integrity: US FDA Guidance Seeks To Head Off Bioavailability/Bioequivalence Study Problems

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