US FDA Sees Major Spike in BA/BE Studies in India
By Zachary Brennan -
Published 19 June 2017
In 2002, the US Food and Drug Administration (FDA) did not conduct any bioavailability (BA) or bioequivalence (BE) study inspections in India for generic drug applications. A little more than a decade later, and nearly half of all FDA's BA/BE study inspections are conducted on the subcontinent.
Categories: News, India, US, CDSCO, FDA, Clinical, Crisis management, Generic drugs, Government affairs
Tags: BA and BE studies, bioequivalence, generic drugs from India