LILLY INFORMED CONSENT FORM FOR FIAU TRIAL WAS "NOT COMPLETE," FDA SAYS
LILLY INFORMED CONSENT FORM FOR FIAU TRIAL WAS "NOT COMPLETE," FDA SAYS in a May 11 warning letter to the company. "The sample ICD [informed consent document] you provided in the protocol was not complete, and you failed to include information regarding all the reasonably foreseeable risks to subjects," FDA told Lilly.
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