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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