Indian CRO Inspection Fall-Out: Semler's Clients Have To Repeat Studies For US FDA
This article was originally published in SRA
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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