Clinical Trial Site Did Not Follow Regulations: FDA

FDA says that a 10/6-10/30/15 Bioresearch Monitoring Program inspection of two clinical trials conducted by Dr. Cheta Nand in Richland, WA, determined that Nand “did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations. A just-released 3/10 Warning Letter says that Nand failed to ensure that the investigation was conducted according to the investigational plan.

The letter six instances in which the investigator failed to follow the investigational plan and says that in each instance the agency was unable to undertake an informed evaluation of Nand’s written response because it did not provide a corrective action plan that, if carried out, would prevent the same type of violation in the future.

Nand was told to respond with a list of actions taken to prevent similar violations in the future.