• 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

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

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