Posted 18 April 2017
By Zachary Brennan
The US Food and Drug Administration (FDA) warning letter released Tuesday says that Los Angeles-based Targeted Medical Pharma ran a clinical investigation of a medical food without first submitting an investigational new drug (IND) application to the agency.
FDA officials advised the company last July, before initiating the clinical trial that “although these were Medical Foods and no NDA would be applied for, Targeted Medical Pharma should still apply for an IND.”
Despite that notification, the company proceeded to enroll 129 human subjects at 11 clinical sites for one protocol and 122 subjects at eight sites for another protocol.
According to the company’s website, Targeted Medical Pharma develops and distributes “amino acid-based medications for a variety of disease states.”
FDA notes that Targeted Medical should have obtained an IND for its trials. The company did not respond to a request for comment and has 15 days to respond to FDA’s warning letter.