US CRO contracted by FDA to answer generics safety questions
Under the contract, Kansas-based VACR will compare generic drugs with innovator products with the initial focus being on anti-epileptic products.
The contract research organisations (CRO)'s president Brad Vince said that: “With this contract we will seek to investigate the bioequivalence of generic products that have resulted in reports of Adverse Events to the FDA.”
He added that: “We are truly excited to partner with the FDA to help address agency concerns with product substitution issues.”
