FDA warns in­ves­ti­ga­tor for vi­o­lat­ing clin­i­cal hold

The US Food and Drug Ad­min­is­tra­tion (FDA) ear­li­er this month warned Faro Owiesy, a physi­cian and clin­i­cal in­ves­ti­ga­tor at the Cal­i­for­nia-based Coro­na Doc­tors Med­ical Clin­ics, for vi­o­lat­ing a clin­i­cal hold and ad­min­is­ter­ing an in­ves­ti­ga­tion­al drug to pa­tients be­fore an in­ves­ti­ga­tion­al new drug (IND) ap­pli­ca­tion went in­to ef­fect.

The warn­ing let­ter comes af­ter FDA in­spect­ed the clin­ic over six days in June as part of the agency’s biore­search mon­i­tor­ing pro­gram and near­ly a year af­ter the agency placed a clin­i­cal hold on a study be­ing con­duct­ed at the site.

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