Investigator Warned for Failing to Report Death, Other SAEs

A cardiologist working as a clinical investigator failed to report serious adverse events (SAEs), including a death, to the sponsor in a timely manner, according to an FDA warning letter. Charles McKay of Torrance, Calif., was cited for his conduct of a drug trial based on an FDA inspection of his site Feb. 24 through March 6. The FDA redacted details about the drug and sponsor from the Oct. 23 warning letter that was posted online Nov. 3.
Clinical Trials Advisor