Drug Master Files: New Implications under GDUFA 2016 covers topics such as:
- 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
Drug Master Files: New Implications under GDUFA 2016 brings together 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
