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CRO Inspection Fall-Out: Semler's Clients Have To Repeat Studies

 
• By Brenda Sandburg

Data integrity spotlight expands beyond cGMP as FDA finds Semler manipulated study subject samples in bioequivalence studies conducted at its Bangalore facility.

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.

The agency said that during an inspection of SRC's Bangalore, India, facility it found the company's practices had "resulted in the submission of invalid study data to FDA

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More from Asia

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