Practical Issues in Combination Products
Primary Mode of Action & Request for Designation AdvaMed MTL Conference -- May 25, 2006
Index of Slides
- Practical Issues in Combination Products Primary Mode of Action & Request for Designation AdvaMed MTL Conference May 25, 2006
- In the beginning…
- Office of Combination Products
- OCP’s Roles:
- OCP Objectives
- In a nutshell
- Where is OCP?
- I am a combination product
- Primary Mode of Action
- PMOA continued
- Mode of Action
- Primary Mode of Action
- PMOA algorithm
- PMOA CDER or CDRH?
- More PMOA examples
- More PMOA examples
- The last PMOA example
- Request for Designation (RFD)
- Who should file an RFD?
- What happens if I don’t file an RFD?
- When should I file an RFD?
- RFD Content
- Guidance Document
- Guidance Document
- RFD Processing
- RFD processing
- What if I disagree with RFD decision?
- What’s the effect of an RFD letter?
- RFD Statistics
- How to find out…
- Intercenter Agreements
- Intercenter Agreements
- Jurisdictional Determinations
- Jurisdictional Updates
- RFD letters
- Examples of Approved Combination Products
- Chemical Action
- Perhaps the easiest way to find out…
- Contact Us!
- Contact Us!
- No Title
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