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

Publications

• FDA's Concerns About Unapproved Drugs
• Background Information
• Unapproved Drugs Initiative
  • Compliance Policy Guide
• Enforcement Actions
  • Drug-Based Actions
  • Firms
• 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
• Important Documents
• Publications

Publications

• Derbis J, Evelyn B, McMeekin J. FDA initiative aims to remove unapproved drugs from market. Pharmacy Today. August 2008.
• Meadows M. The FDA takes action against unapproved drugs. FDA Consumer Magazine. January-February 2007.

Back to Top     Back to Unapproved Drugs

PDF requires the free Adobe Acrobat Reader

Date created: September 23, 2008

CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page

FDA/Center for Drug Evaluation and Research