‘Objectionable Conditions’ at Nevada Clinical Study Site

FDA says an 11/16-11/25/20 Bioresearch Monitoring Program inspection at a clinical study site maintained by Michael Levin, Las Vegas, NV, as the clinical investigator for a redacted study found objectionable conditions that violated the regulations governing the proper conduct of clinical studies involving investigational new drugs. A 3/22 Untitled Letter says Levin failed to ensure that the investigation was conducted according to the signed investigator statement, the investigational plan, and applicable regulations, and failed to protect the rights, safety, and welfare of study subjects under his care.

Levin was told to respond with written documentation of the actions he has taken or will take to correct any violations and prevent the recurrence of similar violations in current and future studies for which he is the clinical investigator.