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Office of New Drug Products

WHO WE ARE:

The Office of New Drug Products (ONDP) conducts risk and team-based, cross-office collaborative quality assessments of Investigational New Drug (IND) submissions, original and some supplemental New Drug Application (NDA) submissions, and active pharmaceutical ingredient (API) information supporting all new and supplemental NDAs and Abbreviated New Drug Applications (ANDAs).

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.
     

Office Organization:

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 
  • Botanical Review Team
  • Environmental Assessment Team

Office Leadership:                              
Director:  Dr. Lawrence Yu
Deputy Director:  Dr. M. Scott Furness    

Resources For You:

 

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