• ANDA review process
• Common review deficiencies
• First cycle approval
• Post approval changes
• Data Integrity issues
• Pre-approval inspections
• Best practices and real-world examples

The objective of this workshop is to share the agency’s expectations and thinking on generic drug life cycle management. The workshop topics are designed to engage participants in active dialogue and to encourage a better understanding of regulatory expectations related to generic drug applications. The ANDA workshop will focus on the best practices in submitting and managing generic drug applications, challenges in application review and submission, regulatory support mechanisms, and real-world examples experienced by FDA regulators . The hopeful outcome of the workshop is to increase compliance to FDA regulatory expectations in future submissions. Workshop participants will have opportunities for questions and answers with FDA subject matter experts.