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Talk to a SpecialistTalk to a SpecialistDr. Lauren R. Klein failed to obtain required Investigational New Drug Applications (INDs) before conducting clinical investigations with investigational drugs—specifically olanzapine, haloperidol, ziprasidone, and midazolam—in violation of 21 CFR 312.20 and 312.40(a). The FDA inspection of her clinical site between April 2019 identified that she did not adhere to statutory requirements and FDA regulations governing the conduct of clinical investigations and protection of human subjects. The violations occurred across two protocols (HSR 17-4345 and HSR 18-4521) studying treatments for acute undifferentiated agitation in emergency department settings.