FDA warns pe­di­atric neu­rol­o­gist for fail­ing to check el­i­gi­bil­i­ty of tri­al par­tic­i­pants

The FDA ear­li­er this month sent a warn­ing let­ter to a child neu­rol­o­gist in Geor­gia for en­rolling sub­jects in­to a clin­i­cal study and a sub­se­quent ex­ten­sion study with­out en­sur­ing their el­i­gi­bil­i­ty for ei­ther study be­fore­hand.

While the warn­ing let­ter redact­ed the de­tails of which par­tic­u­lar study was in­volved, the let­ter was is­sued to Daniel Tar­quinio, a child neu­rol­o­gist and founder of the Cen­ter for Rare Neu­ro­log­i­cal Dis­ease in Nor­cross, Geor­gia, who has worked on rare dis­ease drug tri­als along­side Ul­tragenyx and the Rett Syn­drome Re­search Trust.

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