483
Jennifer W. Leiding M.D.Jennifer W. Leiding M.D. – FDA 483, Sep 8, 2023
Record Details
An FDA inspection of Jennifer W. Leiding, Clinical Investigator, in Seminole, FL, revealed significant deficiencies in the conduct of a clinical study. Observations included failures to obtain proper informed consent, report non-serious adverse events to the sponsor, and maintain accurate case histories by reporting all concomitant medications. These issues indicate a concerning lack of adherence to regulatory requirements for human subject protection and data integrity in clinical trials.
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