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戻る Agenda
On Demand 3 Track 2: Using Type 9 NDA Classification to Accelerate Multiple Approvals for Your Drug Product
Session Chair(s)
David Meats
Director, Regulatory Services Management
Certara, United States
This session describes FDA’s policy regarding US NDA classification codes, Types of NDAs, and Type 9 NDAs in specific. Session attendees will learn the submission process of Type 9 NDA submissions compared to other submission types. Furthermore, the benefits and risks associated with the Type 9 NDA process will be discussed.
Learning Objective : At the conclusion of this session, participants should be able to:
- Recognize the different types of US NDA classification codes
- Understand the risks and benefits of a Type 9 NDA submission
- Judge if a Type 9 submission is right for your product
Speaker(s)
Speaker
Vibha Kumar, PhD
Certara Synchrogenix, United States
Associate Principal Regulatory Writer
Speaker
Elaine Taylor
Certara Synchrogenix, United States
Vice President, Regulatory Services Management