Unapproved Drugs:
Drugs Marketed in the United States That Do Not Have Required FDA Approval

FDA's Concerns About Unapproved Drugs Background Information Unapproved Drugs Initiative Compliance Policy Guide Enforcement Actions Drug-Based Actions Firms Important Documents Publications Podcast: Unapproved Drugs October 10, 2008: Measures Undertaken to Address Concerns About Marketing of Unapproved Drugs October 17, 2008: FDA's Action Against Marketing Unapproved Drugs

Industry Information Unapproved Drug Decision Tree Unapproved Drugs Coordinator Letter to Branded Pharmaceutical Association Regarding Unapproved Drugs Coordinator Marketed Unapproved Drugs Workshop Required reporting of adverse events Health Care Professional Information Determining if a drug is FDA approved Orange Book NDC Directory Drugs@FDA Legal mechanisms to access unapproved drugs Reporting of adverse events Consumer Information

Video: Unapproved Drugs Windows Media Player 56K | 150K | 300K Real Player – Captioned 56K | 150K | 300K Real Player – Non-Captioned 56K | 150K | 300K Enabling Video Captions for Windows Media Player or RealPlayer

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Date created: June 8, 2006; updated October 17, 2008

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