Warning Letter Instructs Sponsor on Clinical Trial Basics

The sponsor of drug-device combination trials failed to submit IND applications, get signed investigator statements and select monitors before beginning the studies, and it did not maintain drug disposition records once the trials were under way, according to an FDA warning letter.

The letter was sent June 30 to Travanti Pharma, a Minnesota company, which is developing wearable electronic drug-delivery patches to dispense a variety of pharmaceuticals, biotechnology compounds and cosmetic ingredients through the skin, according to its website.

The products tested in the clinical trials “appear not to be exempt from [federal] requirements and not within the exemptions … and therefore required an IND,” the warning letter, which was based on an investigation conducted Feb. 19–28, said.

Travanti Pharma did not file investigator statements for any researcher in the studies, so no subinvestigators were listed, according to the letter. The investigators’ financial interests, if any, also were not listed.

Moreover, “the FDA inspection disclosed that your firm did not maintain any documentation to indicate that the [three] studies requiring an IND were adequately monitored” and that the company did not maintain drug accountability records for the studies, the warning letter said.