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Sessions 2, 3, and 4
Session Chair(s)
Albert S. Yehaskel, MBA
President and CEO
Refuah Global Pharmaceutical Development, Inc., United States
Session 2: Types of Submissions Affected by CMC
- FDA Briefing Package
- Investigational New Drug Application (IND)
- Investigational Medicinal Product Dossier (IMPD)
- New Drug Application (NDA/CTD)
- Biologics License Application (BLA)
- Common Technical Document (CTD)
- Drug Master Files (DMFs)
- Abbreviated New Drug Application (ANDA)
- Amendments to an IND
- Supplements to an Approved NDA/ANDA
- IND/NDA Annual Reports
- CMC Steps Leading to an IND
- Key Active Pharmaceutical Ingredient (API) Characteristics
- Development of Analytical Assay
- Preformulation Testing
- Solubility/Stability
- Forced Degradation Studies
- Formulation Development and Challenges
- cGMP Manufacturing
- Requisites for Clinical Trial Materials (CTM) Manufacture
- Stability Testing and Storage
- The meeting package