Adnan Dahdul, MD — FDA Warning Letter Findings

You failed to obtain legally effective informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20]. As a clinical investigator, you are required to obtain informed consent in accordance with 21 CFR part 50. FDA regulations at 21 CFR 50.20 state that, except as provided in 21 CFR 50.23 and 21 CFR 50.24, no investigator may involve a human being as a subject in research covered by the regulations unless the investigator has obtained…

Failure to prepare and maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation. [21 CFR 312.62(b)] A Clinical Investigator is required to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational product or employed as a control in the investigation. For the first 196 subjects enrolled in the…

You failed to ensure that the investigation was conducted in accordance with the signed statement of the investigator and the investigational plan. [21 CFR 312.60]. The investigational plan (the Protocol) required you to ensure that eligibility screening was conducted and documented to determine if subjects were healthy, stable, and did not have any medical or psychiatric issues that may make them ineligible for the study. Study records indicate that you did not conduct a…