Patricia Y. Love, MD, MBA,
Assoc. Director OCP
Index of Slides
- ACT Annual
Meeting November 7, 2005
- Things that
are not combination products
- Combination
Products Vary; 21 CFR 3.2(e)
- Challenge: How
to develop?
- Challenge: How
to develop, cont’d?
- Office of Combination
Products*
- Today’s
Comments
- Pathway Regulatory
Challenge
- Finalized /
Published Documents*
- What is it?
Where does it go?
- Classification
and Assignment
- Combination
Product Assignment
- PMOA Final
Rule
- PMOA Final
Rule, cont’d
- PMOA Final
Rule, cont’d
- PMOA: Three
Hypothetical Examples
- PMOA Final
Rule: Algorithm
- Assignment
Determination Process
- Formal Assignment
- Informal Assignment:
Challenges
- Premarket development
And
Pathway considerations
- Premarket
Review
- Review Process & Coordination
- Development:
Practical Approach
- Development:
Practical Approach, cont’d
- Development:
Practical Approach, cont’d
- Practical pre-clinical
considerations, cont’d
- Practical pre-clinical
considerations, cont’d
- Practical pre-clinical
considerations, cont’d
- Practical development
considerations
- Postmarket
Regulatory Challenges
- Good Manufacturing
Practice Guidance; Draft September 29, 2004
- Good Manufacturing
Practice Guidance; Draft September 29, 2004, cont’d
- Good Manufacturing
Practice Guidance; Draft September 29, 2004, cont’d
- New Information:
Requests for Comment
- New Concepts:
OCP Website, September 2, 2005
- Concept: Safety
Reporting, Postmarket
- Concept: Safety
Reporting, Postmarket, cont’d
- Concept: Safety
Reporting, Postmarket, cont’d
- Concept: Safety
Reporting, Postmarket, cont’d
- Concept: Number
of Marketing Applications
- Concept: Number
of Marketing Applications, cont’d
- Concept: Number
of Marketing Applications, cont’d
- Concept: Number
of Marketing Applications, cont’d
- Concepts: Number
of Marketing Applications & Safety Reporting
- What about
global development issues?
- More Ongoing
- Interim Recommendations
- To Contact
Us
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