Drug Master Files: New Implications under GDUFA 2016

Topics

• Key definitions
• GDUFA background
• Self-identification and fee requirements
• Who in industry is impacted
• Completeness assessments
• New DMF correspondences and meetings
• "Available for Reference" status

Who should Attend

Senior attendees involved or interested in:

• Project Managers
• Regulatory Affairs professionals
• API manufacturers
• QA & QC Managers
• Type II (API) DMF holders
• Generic drug manufacturers
• Consultants
• ANDA sponsors
• Any individuals interested in the generic drug industry