Adnan Dahdul, MD

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

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].

Passage 2

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].

Passage 3

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)]

Passage 4

Failure to address this matter adequately may lead to regulatory action. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration. FDA has several references available at http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm for more information on human subject protection and the conduct of clinical research.