The FDA this week released a warning letter it sent to UVLrx Therapeutics over issues with an unapproved study of an intravascular catheter, citing failures to obtain approval for the trial alongside a number of other violations.
The federal watchdog said that concerns were raised after an inspection performed between March 27 and April 4 this year looking to investigate the company’s sponsorship of clinical trials of a peripheral intravascular catheter.
The FDA warned the company on a failure to obtain approval from the Institutional Review Board for one such trial, saying that in addition company had enrolled too many subjects and had no approval for at least 10 clinical investigators for a trial, though details of the trials were redacted.
“Your firm’s failure to obtain IRB approval is a serious violation of your responsibilities as a sponsor. Without IRB approval, there is no assurance that the rights and welfare of subjects were adequately protected. This includes verifying that the informed consent (IC) was adequate and subjects fully understood the study objectives, procedures, risks and benefits,” the FDA wrote in its warning.
The agency also knocked the company on failures to monitor a study for significant or non-significant risks and a lack of maintaining documentation, which led to investigational products being shipped to unapproved and unqualified investigators.
“Inadequate monitoring can put subjects at risk: potential defects with the device and its performance; adverse events which may affect subject safety; and protocol deviations that may affect subject safety and data integrity. Sponsor monitoring is also necessary to confirm that the investigational device is shipped and used only by qualified investigators on subjects appropriately enrolled in the study. If the device were used by unqualified individuals on patients not enrolled in the study there could be an increased risk of harm to the patient,” the FDA wrote.
The federal watchdog went on to note failures to maintain documents of adverse events and failures to label an investigational device as such, citing serious concerns over the health and safety of subjects associated with the trial.
The FDA said it had received a response that acknowledged the violations and placed blame on “inadequate management received from the former CRO, Ryan Maloney,” but said that as sponsors of the trial, the firm “is responsible for all oversight governing the clinical studies.”
The agency went on to request appropriate corrections, including appropriate documentation and action plans to correct the outlined issues. The company was given 15 working days to provide the requested corrections, with a threat of further regulatory action if it is not received.