Eye on Roche after failure to report side effects

Inspectors at the Basel-based company's British site in Welwyn found deficiencies related to Roche's global process of detecting and reporting the adverse effects of medicines.

At the time of the inspection, 80,000 reports for medicines marketed by Roche in the US had been collected through a Roche-sponsored patient support program, but had not been evaluated to determine whether they should be reported to the EU authorities as suspected adverse reactions.

"These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link

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