Regulation of
Combination Products:
Progress Report
DIA Webinar (1-19-05)
Index of Text Mostly Slides
- Regulation of Combination
Products: Progress Report
- What We’ll
Cover
- Combination Products
Are Diverse
- Combination Products
Are Diverse
- Regulatory Approaches
Are Diverse
- Challenges: Overall
Regulation
- Challenges: Overall
Regulation
- The Ultimate Regulatory
Challenge
- Challenges: Assignment
- Challenges: Assignment
- Challenges: Assignment
- Challenges: Assignment
- Challenges: Review
- Challenges: Review
- Challenges: Review
- No Title
- Jurisdictional
Determinations
- How do we do it?
- PMOA Proposed Rule:
May 7, 2004 Federal Register
- PMOA Proposed Rule:
May 7, 2004 Federal Register -- continued
- PMOA Proposed Rule:
May 7, 2004 Federal Register -- continued
- PMOA Proposed Rule:
May 7, 2004 Federal Register -- continued
- PMOA Proposed Rule:
May 7, 2004 Federal Register -- continued
- PMOA: Three Hypothetical
Examples
- PMOA Proposed Rule:
Selected Stakeholder Comments
- OCP Assignments
of Combination Products (10/1/03 through 9/30/04)
- OCP Classification
Decisions (Non-Combination Products (10/1/03 – 9/30/04)
- Application User
Fee Guidance
- No Title
- Premarket Review
- How do we do it?
- How do we do it,
more
- Intercenter Consultation
Requests 10/01/03 through 9/30/04
- Resource for Industry
and Review Staff
- How do we do it?
- Common questions
from industry and staff
- Number of Marketing
Applications
- Dispute Resolution
- Dispute Resolution
Guidance, Draft
- Postmarket Regulation
- How do we do it?
- Good Manufacturing
Practices Guidance
- Good Manufacturing
Practice Guidance, cont’d
- Good Manufacturing
Practice Guidance, cont’d
- Good Manufacturing
Practice Guidance, cont’d
- Postmarket regulation
- Safety Reporting:
postmarket
- Safety Reporting
- General Considerations
for combination product development
- Wrap - Up
- What’s Still
Left to be Done: A Lot
- What’s Still
Left to be Done: A Lot
- The Future is
Bright!
- OCP Website: http://www.fda.gov/oc/combination/
- Contact Us – Office
of Combination Products
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