| Document Date: 2013-11-14 10:27:36
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City Katy Freeway Houston / Philadelphia / Freeway Houston / / Company Burzynski Research Institute Inc. / AEs / Neuro-Oncology Working Group / CVs / Rosenberg SA / / Facility Burzynski Clinic / Freeway Houston / Burzynski Research Institute / / IndustryTerm insurance problems / insurance / magnetic media / / MedicalCondition catheter infection / tumor / High Grade Gliomas / recurrent glioblastoma / Cancer / research-related injury / tumors / headache / hypernatremia values / glioblastoma multiforme / Progressive disease / nausea / patient’s enhanced tumor / target tumor / hypernatremia / drug usage / injury / neoplastic disease / stable disease / malignant brain tumors / illness / cyst / amended tumor / brain tumor / / MedicalTreatment radiation therapy / catheter / chemotherapy / surgery / investigational treatment / / Organization IRB / FDA / Quality Assurance Department / / Person Perry JR / Burzynski / / Position Investigator / Clinical Research Assistant / local physician / Principal Investigator / translator / correct investigator / clinical investigator / Research Associate / / ProvinceOrState South Dakota / Texas / Indiana / / PublishedMedium British Journal of Cancer / the QA Monitor review / / Technology radiation / chemotherapy / MRI / four protocols / /
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P a g e |1 Responses to January 17th to March 15th, 2013 (FDA-483) Inspectional Observations Observation 1 Failure to monitor the progress of an investigation conducted under your IND. Specifically,