FDA’s Final Compliance Policy Guide for Marketed Unapproved Drugs ─ Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle?

August 16, 2006 Download PDF

In June 2006, the FDA issued its long-awaited Compliance Policy Guide (“CPG”) concerning the Agency’s enforcement priorities and policies for marketed unapproved drugs. FDA’s final CPG is part of FDA’s ongoing drug safety initiative.