Blog — Clinical Pathways

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violation

Investigator Warning Letter: Lapse in IRB Approval

03/15/2022

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In a recent investigator warning letter issued by the US Food and Drug Administration (FDA), an investigator was cited for failing to ensure an Institutional Review Board (IRB) that complies with the applicable regulatory requirements in 21 CFR 56 was overseeing their clinical trial. During the time where IRB approval for the protocol lapsed, the site continued to enroll and administer investigational products to study participants under that protocol. The investigator’s response to the FDA was inadequate because they explained that they did not need to report any adverse events during that timeframe.

Document Retention Investigator Warning Letter

02/01/2022

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A recent US Food And Drug Administration (FDA) investigator warning letter focused on record retention. According to FDA regulations, site records must be retained for at least two years after a marketing application is approved or two years after the study is closed (21 CFR 312.62(c)).

Device Sponsor Warning Letter: No PMA or IDE

7/13/2021

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A recent US Food and Drug Administration (FDA) warning letter to a device sponsor involves the sponsor marketing a device used for dialysis without an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). The device was previously cleared through the 510(k) pathway. However, the sponsor made significant changes to the design and function of the device.