The Food and Drug Administration (FDA) found numerous “objectionable conditions” during an inspection last summer of research conducted by Kang Zhang, professor of ophthalmology and chief of ophthalmic genetics at University of California San Diego, the agency said in a Jan. 5 “warning letter” recently posted online. “[W]e conclude that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations,” FDA said, a finding that references both the inspection and Zhang’s response to it in a subsequent letter to the agency. “FDA is particularly concerned that you enrolled six of the twelve subjects enrolled into this study without ensuring their subject eligibility,” the agency said. “Your inability to account for the disposition of 25 units of unused supplies of study drug raises significant concerns regarding the adequacy of your oversight and control of investigational drug. In addition, your failure to maintain adequate and accurate drug accountability records raises concerns about the validity and integrity of the data collected at your site.” The agency requested that Zhang “notify this office in writing of the actions you have taken to prevent similar violations in the future,” and that, in the event “you believe you have complied with FDA regulations, include your reasoning and any supporting information for our consideration.” According to the letter, “failure to address the violations noted above adequately and promptly may result in regulatory action without further notice.” The letter does not describe the research in any detail but notes that Zhang is “both the sponsor and a clinical investigator” of the drug under study.
Link to full article: http://tinyurl.com/zvqbjwe.