Regulation of Biologics and Biotechnology Products in the United States and Europe
Susan O'Shea
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- Regulation of Biologics and Biotechnology Products in the United States and Europe University of Rhode Island College of Pharmacy Jurisdictional Issues within FDA: Who Decides?
- Jurisdictional Issues
- Who does what?
- If the question is…
- Option 1: Tissue Reference Group
- Tissue Reference Group
- Tissue Reference Group
- What happens if I disagree with TRG?
- Office of Combination Products
- OCP’s Missions
- Where is OCP?
- What process does OCP use?
- RFD Guidance Document
- RFD Guidance Document
- How does OCP decide?
- What if I disagree with OCP’s conclusion in an RFD?
- If the question is…
- In general, CBER kept
- Biological Products Transferred to CDER
- If there’s still a question
- What about Combination Products?
- Primary Mode of Action
- PMOA
- PMOA Algorithm
- PMOA
- RFD Guidance Document
- The Bottom Line
- No Title
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