STAT+: European regulator suspends generic drugs after finding flawed studies
In the latest dust-up over the safety of medicines, the European Medicines Agency recommended suspending marketing authorization for dozens of generic drugs after finding problems with tests conducted by a clinical research organization.
Specifically, the regulator pointed to “serious concerns” about the quality and reliability of data in bioequivalence studies run by Synchron Research Services, which is based in Ahmedabad, India. Bioequivalence studies are conducted to show that a generic medicine releases the same amount of an active ingredient in the body as a brand-name medicine.
Continue to STAT+ to read the full story…
