Recovery of Investigational New Drugs From Clinical Investigators; Revised Compliance Policy Guide; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of revised compliance policy guide (CPG) 7132c.05 entitled, ``Recovery of Investigational New Drugs from Clinical Investigators.'' Revised CPG 7132c.05 deletes obsolete drug citations in the Code of Federal Regulations. These references were superseded under the investigational new drug rewrite (IND Rewrite). Revised CPG 7132c.05 clarifies the terminology used to classify the recovery of investigational new drugs from clinical investigators consistent with existing regulations. In addition, consistent with the current CPG, this policy continues to apply to new animal drugs being studied under investigational new animal drug applications.