Regulatory Affairs Part II: The NDA Phase
Venue: Drug Information Association, Inc.
Location: Horsham, Pennsylvania, United States
Event Date/Time: Mar 08, 2010 | End Date/Time: Mar 10, 2010 |
Description
What you will learn
• Overview and roles and responsibilities of FDA
• NDA in CTD format
• Regulatory compliance and FDA inspections
• Post-approval regulatory requirements for NDAs
• Regulatory requirements for prescription drug/biologics labeling
• Regulatory requirements for prescription drug/biologics advertising
• How to interact with the FDA