Blogs

The US Food and Drug Administration (FDA) has released a new guidance, Marketed Unapproved Drugs—Compliance Policy Guide, that outlines the agency’s risk-based enforcement priorities for drugs marketed without proper regulatory approval. The guidance updates the previous version from June 2006. The agency notes that since it lacks the resources to take immediate action against all illegally marketed products, it must give higher priority to enforcement against unapproved products in certain high-risk categories, such as drugs that pose serious safety risks, those that lack evidence of effectiveness, reformulated drugs and drugs promoted through deceptive or fraudulent advertising practices.

Read more:

• FDA Publishes Guidance on Marketed Unapproved Drugs (Pharmaceutical Technology)
• Reformulation targeted in FDA unapproved drug plan (in-PharmaTechnologist)
• FDA Ramps Up Enforcement on Marketed Unapproved Human Drugs – Revised CPG Says New Products Will be Subject to Immediate Enforcement Action (FDA Law Blog)
• Marketed Unapproved Drugs—Compliance Policy Guide (FDA.gov)