FDA and CDC Sign Memorandum of Understanding for Select Agent and Toxin Clinical Trials

Summary

The Food and Drug Administration (FDA) has signed a Memorandum of Understanding (MOU) with the Division of Select Agents and Toxins (DSAT) of the Centers for Disease Control and Prevention (CDC) to establish procedures for FDA to confirm acceptance of Investigational New Drug applications, Investigational New Animal Drug files, or Investigational Device Exemption applications for clinical trials involving select agents or toxins.