FDA Issues Warning Letter to Principal Investigator: The Excuse Pushed us to Report on the Incident

FDA Issues Warning Letter to Principal Investigator The Excuse Pushed us to Report on the Incident

Earlier this year, the Food and Drug Administration’s (FDA) Bioresearch Monitoring Program summarized an inspection of principal investigator (PI) Susan P. King-Harris, D.P.M., who was conducting a sponsor-initiated clinical trial involving bunion surgery. Led by the FDA’s Andrace Deyampert, the agency reviewed the principal investigator’s conduct as the sponsor and PI of the clinical trial. After an unsatisfactory response from the PI, the FDA issued a Form 483 (inspection observations) Warning Letter to the Michigan-based podiatrist for conducting a clinical trial without confirming whether the study participants were eligible prior to enrollment. This represents a notable deviation from the investigational plan—in our view—evidence of an aloof behavior that by itself didn’t merit a write up in this media—till we read the excuse and that pushed us over the edge to comment.
The Issue
The clinical research related to a bunion surgery procedure. The inclusion criteria required patients to have a bunion severity determined by the intermetatarsal angle (IMA), which requires to be between 10 and 15 degrees. Patients with greater than 15 degrees were to be excluded from the study. Durin...

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