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3: Regulatory Processes Leading to NDA Submission

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Learning Objectives:
  • Evolution of Drug Regulation in the US
  • Drug Development Pathway and Milestones
  • Phases of Development
  • Key Areas to Consider for a NDA Submission
  • Meeting with the FDA
  • Building the NDA – the Common Technical Document
  • Expedited Development and Approval Pathways
  • Post Submission – what to expect?
  • Guidance Documents and Literature