Have MDUFMA's performance goals affected product review quality?
This article was originally published in Clinica
FDA officials have launched a retrospective investigation into whether product review quality has declined now that staff must comply with ever more demanding user fee performance goals. To gauge the potential impact, the agency has established quality assessment teams who will have been asked to scrutinise a selected sample of recently completed reviews focusing in particular on three issue areas - biocompatibility, sterility and statistics that are common to all reviews.
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