Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
|Videos|May 11, 2023
Frequently Asked Questions about Combination Products
Author(s)Nelson Labs
KEY LEARNING OBJECTIVES
- Understand what constitutes a combination product
- Gain a basic understanding of the process for combination product regulatory filing
- Understand the basics concepts of the FDA Principles of Premarket Pathways for Combination Products: Guidance for Industry and FDA Staff, January 2022
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