• Fundamentals of the Investigational New Drug (IND) and New Drug Application (NDA)
• Preparation
• Content
• FDA review of applications
• Amendments and maintenance
• Regulatory strategy
• What to expect at meetings and in other interactions with FDA
• Regulatory requirements of prescription drug labeling and promotion
• Adverse event reporting and risk management in the pre- and post-marketing settings
• Post-marketing requirements
• Sources of regulatory intelligence information

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

• Recognize the importance of incorporating regulatory strategy into the drug development plan
• Identify regulatory programs and mechanisms that can facilitate and expedite new drug development
• Identify content and format requirements for INDs and NDAs
• Outline the requirements for submitting INDs, NDAs, amendments, and NDA supplements
• Explain the FDA review processes for evaluating INDs and NDAs
• Define NDA post-approval responsibilities and requirements
• Determine how to report adverse events in accordance with FDA pre-marketing and post-marketing regulations
• Apply sound meeting practices and productive dialogue principles when interacting with the FDA
• Outline the regulatory requirements for prescription drug labeling and promotion
• Identify resources for regulatory intelligence