FDA Guidance Provides Notice that Newly Marketed Unapproved Products May be Subject to Immediate Enforcement Action

On September 19, 2011, the U.S. Food and Drug Administration (FDA) published a revision of the agency’s June 2006 guidance document, entitled Marketed Unapproved Drugs—Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs. The revised guidance document reaffirms the agency’s risk-based enforcement approach and enforcement priorities for unapproved drug products and provides notice to drug companies that any unapproved drug products brought to market on or after September 19, 2011, will be subject to immediate enforcement action.

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