483
Jeffrey S. Dome, M.D.Jeffrey S. Dome, M.D. – FDA 483, Apr 12, 2021
Record Details
Jeffrey S. Dome, M.D., a clinical investigator in Washington, DC, was cited with two observations during an FDA inspection. The observations relate to failures in clinical trial conduct, specifically regarding adverse event reporting and informed consent procedures. These issues indicate deficiencies in adherence to study protocols and regulatory requirements for protecting human subjects.
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ID · 155c4f90-4ad4-4b76-aa02-94676f1f2b7c
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