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U.S. Department of Health and Human Services


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Marketed Unapproved Drugs Workshop (January 9, 2007): Meeting Presentations

  • Introductions for the Marketed Unapproved Drugs Workshop [PDF]
  • The Unapproved Universe [PDF]
  • Regulatory Pathways: OTC Monographs [PDF]
  • Chemistry, Manufacturing, & Controls (CMC) Requirements [PDF]
  • Regulatory Pathway: Abbreviated New Drug Application [PDF]
  • Regulatory Pathways: NDA Process [PDF]
  • NDA: Demonstrating Product Effectiveness [PDF]
  • Preclinical Safety Requirements [PDF]
  • Demonstrating Clinical Drug Safety [PDF]
  • Pediatric Studies [PDF]
  • Patent and Non-Patent Exclusivities [PDF]
  • Prescription Drug User Fees [PDF]
  • Coordinator Role [PDF]
  • Unapproved Drug Decision Tree [PDF]

Meeting agenda and all presentations [PDF, 4.8 MB]