FDA faults IQVIA for er­rors in opi­oid sales da­ta, calls for qual­i­ty re­view

The FDA is call­ing up­on IQVIA to re­view its da­ta qual­i­ty and method­olo­gies af­ter find­ing er­rors re­gard­ing sales vol­ume da­ta on cer­tain con­trolled sub­stance, in­clud­ing opi­oids. Cit­ing “se­ri­ous con­cerns about sys­temic is­sues with IQVIA’s da­ta and qual­i­ty con­trol pro­ce­dures,” the agency has re­quest­ed IQVIA run an in­de­pen­dent au­dit.

In a state­ment, IQVIA — the world’s largest clin­i­cal out­sourc­ing firm and a wide­ly used da­ta ven­dor — said it’s been ad­dress­ing the is­sue, which it had al­ready iden­ti­fied pri­or to the no­ti­fi­ca­tion. It al­so says it’s work­ing with the FDA to re­solve con­cerns — some­thing that the FDA ac­knowl­edged in its own re­lease.

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