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Session 3: Industry Best Practices and FDA Feedback on Optimal Combination Product Submissions
Session Chair(s)
Demetra Macheras, MBA
Director, Regulatory Policy and Intelligence - Regulatory Affairs
AbbVie, United States
Have you ever struggled with how and where to address certain information within your combination product submission? This session will provide an overview of pitfalls and lessons learned from both industry and FDA regarding where information is best located to provide a clearly structured and efficient combination product submission to FDA. Topics to be covered will include key FDA guidance and resources that support the location of key combination product information, real world experience from industry, and pitfalls and best practices in the structure and format of combination product submissions experienced by both CDER and CBER.
Learning Objective : At the conclusion of this session, participants should be able to:
- Define FDA guidances and resources that address FDA expectations for the location of key information in a combination product submission
- Explain industry knowledge and lessons learned on where to locate certain combination product-related information within a submission
- Understand FDA recommendations on where to locate key information in a combination product submission
Speaker(s)
Evolution of the NDA/BLA Content for a Combination Product
Susan Holmes, MSc
GlaxoSmithKline, United States
Director
Best Practices and Recommendation for Combination Product Submissions to CDER
Kristina Lauritsen, PhD
FDA, United States
Combination Products Regulatory Policy Advisor, OEP, CDER
Considerations for Submission of Device Information
Sarah Mollo, PhD, RAC, PhD, RAC
FDA, United States
Combination Product Policy Analyst, OPEQ, CDRH
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