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Learn about FDA regulations and expectations for the content, submission, and review of INDs/NDAs and the importance of regulatory strategy. This comprehensive course employs a blend of lectures, workshops and online precourse modules. The course focuses on drug and well characterized biological products and not the regulatory process for devices, generic products, or traditional biologics.
Course Level: Beginner

What you will learn

  • Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA) Processes
    • Preparation
    • Content
    • Strategy
  • Meetings and other interactions with FDA
  • Prescription Drug Labeling
  • Postmarketing Requirements

Who should attend?

  • Regulatory affairs professionals new to the IND/NDA processes
  • Clinical research and development professionals
  • Biostatisticians
  • Basic researchers
  • Quality and manufacturing professionals
  • Medical writers
  • Business professionals
  • Project Managers

Learning objectives

At the conclusion of this activity, participants should be able to:

  • Explain the importance of incorporating regulatory strategy into the drug development plan
  • Recognize content and format requirements for IND/NDA in the Common Technical Document (CTD) Format
  • Plan and prepare an IND/NDA, and know the reporting requirements for IND/NDA amendments
  • Identify FDA review processes for evaluating IND/NDAs
  • Define NDA post-approval responsibilities and requirements
  • Identify regulatory mechanisms to facilitate development of new therapies
  • Report adverse events in accordance with current FDA  regulations 
  • Apply formal meeting principles and practices when interacting with the FDA
  • Outline the regulatory requirements for prescription drug labeling