FDA warns Genentech clinical investigator working on preventive flu antiviral trial

The FDA on Tues­day re­leased a warn­ing let­ter that it sent to a clin­i­cal in­ves­ti­ga­tor in­volved in Genen­tech’s Phase II­Ib tri­al for the an­tivi­ral Xofluza (balox­avir mar­box­il) for re­duc­ing flu trans­mis­sion from oth­er­wise healthy pa­tients to house­hold con­tacts.

The reg­u­la­tor said the in­ves­ti­ga­tor — Melanie Hop­pers, co-founder and chief med­ical of­fi­cer at Physi­cians Qual­i­ty Care in Jack­son, TN — failed to ad­here to sev­er­al re­quire­ments in the study pro­to­col for six sub­jects.

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