US CRO contracted by FDA to answer generics safety questions

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US CRO contracted by FDA to answer generics safety questions
CRO Vince & Associated Clinical Research (VACR) has won a $5m grant to conduct bioequivalence studies for the US FDA.

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​.”

Related topics: Clinical Development, Phase III-IV

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