US lawmakers probe Actavis's generic drug approvals
This article was originally published in Scrip
Actavis's ANDA approvals are being scrutinised by US lawmakers investigating FDAoversight of drug safety and manufacturing violations.
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With inspectors no longer out in the field, they have more time to wrap up work on previously completed facility evaluations, attorney Howard Sklamberg says; inspections freeze could delay manufacturers’ abilities to bring facilities into compliance following adverse inspection findings, as well as agency reclassifications of facility status.
Experience and data from the study, which will use the same vector platform to deliver different transgenes for different diseases, could feed into the US FDA’s efforts to establish a public-private partnership to enable manufacturing of gene therapies for ultra-rare diseases.
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