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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, OTC 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
  • What to expect at meetings and other interactions with FDA
  • Regulatory Requirements of Prescription Drug Labeling and Advertising
  • 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
  • Communicate the requirements for submitting INDs/NDAs and amendments
  • Describe the FDA review processes for evaluating INDs/NDAs
  • Define NDA post-approval responsibilities and requirements
  • Identify regulatory mechanisms to facilitate development of new therapies
  • State how to 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 and advertising