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Mar 22, 2021 9:50 AM - Mar 24, 2021 2:30 PM

(Eastern Standard Time)

Medical Affairs and Scientific Communications Forum

On Demand 3 Track 2: Using Type 9 NDA Classification to Accelerate Multiple Approvals for Your Drug Product

Session Chair(s)

David  Meats

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


Vibha  Kumar, PhD


Vibha Kumar, PhD

Certara Synchrogenix, United States

Associate Principal Regulatory Writer

Elaine  Taylor


Elaine Taylor

Certara Synchrogenix, United States

Vice President, Regulatory Services Management

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