FDA Sponsor-Investigator Warning Letter

FDA posted a warning letter this week to a Sponsor-Investigator

Targeted Medical Pharma, Inc. was warned for:

  • Failing to submit an IND
    • The company responded to the 483 received after the inspection by stating they were testing a medical food. The FDA warning letter reviews the criteria for medical food and determines that this threshold was not met.
    • The company responded to the 483 by stating an employee had "reached out" to the FDA and been told that the product was a medical food but an IND "should still be applied for". The company states that a Form 1571 and Form 1572 had been submitted to the agency in the 483 response. FDA states that no IND number was assigned and there is no evidence that the forms were ever submitted. 
    • FDA notes that under two protocols, two hundred and fifty one subjects were enrolled across multiple sites for the trials.