FDA EIR - University of North Carolina at Chapel Hill (UNC) RDRC - September 16, 2019

An FDA inspection of the University of North Carolina at Chapel Hill (UNC) Radioactive Drug Research Committee (RDRC) was conducted from September 9-16, 2019. This initial inspection, performed under the guidelines for Radioactive Drug Research Committees (CPGM 7348.809A) and referencing 21 CFR 361.1(c)(2), identified two significant observations. Firstly, the RDRC approved three studies involving human subjects without documenting the numerical results of votes taken during a convened meeting. This practice could compromise the committee's oversight and potentially impact subject safety. Secondly, the RDRC Chairman had not signed the minutes for numerous committee meetings dating from January 2016 to July 2019, indicating a lack of formal documentation of review. In response to these findings, UNC management informed the FDA that the RDRC has implemented changes to ensure all study protocols are now voted upon at convened meetings with recorded vote counts. They also acknowledged the issue with unsigned minutes and committed to providing a written response to the FDA Form 483, which was subsequently submitted on September 26, 2019. The inspection report will undergo further review by the Center for Drug Evaluation and Research (CDER).