US drug regulator warns manufacturers that it will not accept data from Indian research centerBMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i2476 (Published 29 April 2016) Cite this as: BMJ 2016;353:i2476
- Owen Dyer
The US Food and Drug Administration has warned an unspecified number of drug makers that marketing applications containing clinical trial data prepared by an Indian contract research organization will not be accepted because of concerns about the integrity of the data.
An FDA inspection last October at Semler Research Center, based in Bengaluru (Bangalore), found “significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.”1
The agency warned, “FDA is notifying sponsors …