U.S. FDA Cleared GVK Bio With Few Minor Observations
This article was originally published in PharmAsia News
Executive Summary
An audit conducted jointly by the U.S. FDA, European Medicines Agency and a representative of the Netherlands government last September passed GVK Biosciences’ Hyderabad clinical research unit with only a few minor observations, after the Indian CRO came under fire from the European regulatory agency for alleged manipulation of ECG-related data.