WHO WE ARE
The Office of New Drug Product (ONDP), part of CDER’s super Office of Pharmaceutical Quality, protects and advances the public health through review and regulation of pharmaceutical quality in drug substance and new drug products.
WHAT WE DO
- Conducts team-based, cross-office collaborative evaluation and assessment of Investigational New Drug (IND), original New Drug Application (NDA) submissions, and Active Pharmaceutical Ingredient (API) information supporting all new and Abbreviated New Drug Applications (ANDAs).
Perform assessment of the biopharmaceutics information in INDs, NDAs, and ANDAs, and advance biopharmaceutics regulatory science and Physiologically Based Biopharmaceutics Modeling (PBBM).
Conveys risk-informed recommendations on the approvability of such products to appropriate stakeholders within Office of New Drugs (OND), other offices within Office of Pharmaceutical Quality (OPQ), industry, and are responsible for the communication of product-specific residual risk identified in the pre-marketing arena.
Serves as a Liaison between OPQ and OND, works collaboratively with other OPQ offices to conduct application reviews and participates in inspections, as needed.
Modernize pharmaceutical quality assessments and submission tools that support review and regulation of API and new drug products and facilitate knowledge management.
Provide subject matter expertise in the development of policies and procedures governing the quality evaluation of API and new drug products.
These organizations report to the Office of New Drug Products:
- Division of Life Cycle API
- Division of New Drug API
- Division of New Drug Products I
- Division of New Drug Products II
- Division of New Drug Products III
- Division of Biopharmaceutics
- Environmental Assessment Team
- Office of Pharmaceutical Quality
- Pharmaceutical Quality Resources
- Office of Pharmaceutical Quality Reports
- Report on the State of Pharmaceutical Quality
- White Paper: FDA Pharmaceutical Quality Oversight