FDA's SOP For FDA's PV Inspectors

By Bart Cobert

In December 15, 2012 FDA issued its updated Chapter 53 on Postmarketing  Adverse Drug Experience (PADE) Reporting Instructions. This is part of FDA’s Compliance Program Guidance Manual but is, in reality, more or less an SOP for FDA’s inspectors. Although there is nothing really new, it is worth reading to review what FDA will look for during an inspection of your company or a vendor handling drug safety and/PV.

We’ll give a summary of some of the key points here. Much of the content explains the interactions between the PV Compliance Team in the Office of Compliance and the Office of Scientific Investigations. If you are interested in these internal FDA interactions, please see the document as we’ll not cover them here.