Unapproved Drug Enforcement Policy Revised by FDA

On September 19, 2011, FDA published a Notice to Industry announcing its revised Guidance for Marketed Unapproved Drugs – Compliance Policy Guide, replacing the version previously released in June 2006.

This guidance represents a shift in FDA’s approach to enforcement actions related to marketed drugs without approved NDAs, ANDAs or OTC monograph compliance.  To learn how PDG can help you ensure compliance with this, or other FDA mandates, contact us now.