In a rare move, FDA has sent letters to NDA and ANDA sponsors telling them that they will have to repeat bioequivalence and bioavailability studies conducted by the contract research organization Semler Research Center Private Ltd. for their approved products and pending applications.
CRO Inspection Fall-Out: Semler's Clients Have To Repeat Studies
Data integrity spotlight expands beyond cGMP as FDA finds Semler manipulated study subject samples in bioequivalence studies conducted at its Bangalore facility.
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