FDA warns UVLrx Therapeutics over clinical trial missteps

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 dev...
Source: Mass Device - Category: Medical Devices Authors: Tags: Catheters Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Vascular uvlrxtherapeutics Source Type: news