戻る Agenda
Session 1: Types of Submissions Affected by CMC
Session Chair(s)
Priya Jambhekar
President
PBS Regulatroy Consulting Group, United States
- FDA Briefing Package
- Investigational New Drug Application (IND)
- Investigational Medicinal Product Dossier (IMPD)
- New Drug Application (NDA/CTD) and Biologics License Application (BLA)
- Common Technical Document (CTD)
- Drug Master Files (DMF)
- Abbreviated New Drug Application (ANDA)
- Amendments to an IND
- Supplements to an Approved NDA/ANDA
- IND/NDA Annual Reports