EMA recommends suspending medicines over flawed studies at GVK Biosciences

A number of medicines for which authorization in the European Union was primarily based on clinical studies conducted at contract research organization GVK Biosciences in Hyderabad, India, should be suspended, says the European Medicines Agency.

The recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders.

Medicines considered critically important for patients to remain available