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Basics of the NDA Phase


This training course will discuss the aspects of New Drug Application (NDA) preparation. 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 NDA process
  • Post-approval marketing requirements for NDAs
  • Meetings and other interactions with FDA
  • Historical perspectives of pharmaceutical and biologic regulation
  • Key legislative milestones and impact on product development
  • Overview of the organization, roles, and responsibilities of FDA
  • Key regulatory definitions
  • Three stages of new pharmaceuticals and biologics
  • Overview of chemistry manufacturing and controls processes
  • Highlights of nonclinical studies
  • Description and definition of clinical phases of study
  • Expectations after the approval of new products

Who should attend?

  • Regulatory affairs professionals new to the NDA
  • Clinical development professionals
  • Biostatisticians
  • Basic researchers
  • Quality professionals
  • Medical writers
  • Clinical research academicians
  • Business and marketing professionals

Learning objectives

Participants who complete this course should be able to:

  • Explain the importance of incorporating regulatory strategy into the drug development plan
  • Identify FDA review processes for evaluating NDAs
  • Recognize content and format requirements for NDA/BLA in the Common Technical Document Format
  • Define post-approval requirements
  • Outline the regulatory requirements for prescription drug labeling and advertising/promotion
  • Apply formal meeting principles and practices when interacting with the FDA during the NDA phase