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  • Regulatory NewsRegulatory News

    EMA Reviewing Indian CRO Semler After FDA Warns of Data Integrity Issues

    The European Medicines Agency (EMA) on Friday announced it is reviewing all EU-authorized drugs that relied on studies conducted by contract research organization (CRO) Semler Research after recent inspections uncovered serious data integrity violations at its Bangalore, India facility. EMA says it is conducting its review based on the issues raised by recent notices from the US Food and Drug Administration (FDA) and World Health Organization (WHO). According to EMA, th...