Pharmaceutical Consultant – Marketed Unapproved Drugs

FDA has long held the position that they are subject to take aggressive action against companies that market drugs they consider unapproved. FDA’s most recent notice to industry stated that “any unapproved new drug introduced onto the market after September 19, 2011 will be subject to immediate enforcement action, without prior notice and without regard…

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…