483
Marina Nikanorova, M.D.Marina Nikanorova, M.D. – FDA 483
Record Details
This FDA Form 483 was issued to Marina Nikanorova, M.D., a clinical investigator in Dianalund, Denmark, following an inspection related to a clinical trial for Dravet Syndrome. The inspection revealed significant deficiencies in record-keeping for efficacy endpoints, failures in obtaining informed consent under non-coercive circumstances, and improper documentation of consent forms. These issues indicate a lack of adherence to investigational plans and proper clinical trial conduct.
- Company
- Marina Nikanorova, M.D.
- Product type
- drugs
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ID · c7a54aa9-9cab-4d36-beee-5dfc6cfadc6d
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