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