Verdure Sciences Did Not Submit Trial IND: FDA

A 6/25-7/12 FDA Bioresearch Monitoring Program inspection at Verdure Sciences in Noblesville, IN, found that the company failed to submit an IND as the sponsor of a clinical investigation of its investigational drug Maplifa. An 11/10 Warning Letter says the company indicated it did not believe an IND was required because the test protocol assessed the use of Maplifa on the cosmetic appearance of skin photoaging and was not being studied for a use to affect the structure or function of the body or to prevent, treat, mitigate, cure, or diagnose a disease. The company also suggested that because it signed a clinical study agreement with a third-party vendor to conduct the study, the sponsor obligation was transferred to that vendor.

The Warning Letter rejects each of Verdure’s arguments and tells the company to respond with a list of specific actions it has taken to prevent similar future violations.