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Marketed Unapproved Drugs Meeting, January 9, 2007
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]
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Date created: January 16, 2007 |
