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Indian CRO Inspection Fall-Out: Semler's Clients Have To Repeat Studies For US FDA

This article was originally published in SRA

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Executive Summary

In a rare move, the US Food and Drug Administration has sent letters to sponsors of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) telling them that they will have to repeat bioequivalence and bioavailability studies conducted by the Indian contract research organization Semler Research Center Private Ltd. for their approved products and pending applications1.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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