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Office of Lifecycle Drug Products

WHO WE ARE:
The Office of Lifecycle Drug Products (OLDP) assures drug product quality during the lifecycle of both brand name and generic drug products.  

WHAT WE DO:

  • Evaluates and assesses post-marketing chemistry, manufacturing and control (CMC) changes and monitors related activities for brand name drug products (i.e., New Drug Applications, NDA) to ensure their quality throughout the lifecycle. Serves as a liaison to the Office of New Drugs (OND) in providing quality input to ensure product safety and efficacy.  
  • Evaluates and assesses product quality aspects of original Abbreviated New Drug Applications (ANDA) and makes risk-informed recommendations on the approvability of such products to appropriate stakeholders (e.g., Office of Generic Drugs (OGD), other offices within Office of Pharmaceutical Quality (OPQ), industry, etc.).
    • Performs team-based assessments that include cross-office collaboration and participation in inspection where necessary. The output of this office will be a determination that a given ANDA is likely to produce a suitable generic equivalent to a reference listed drug (RLD) product.
    • Serves as a Liaison to OGD and is responsible for the following components of ANDA related to product quality: formulation/product design, identifying potential failure modes, risk assessment, quality standards, clinically relevant specifications, including those related to biopharmaceutics, product characterization, method validation, control strategy relating to product attributes, container/closure system and stability. 
  • Evaluates and assesses post-marketing CMC changes and monitors related activities for generic drug products to ensure their quality, safety and efficacy in collaboration with other OPQ offices and OGD throughout the lifecycle.
  • Provides scientific input in establishing public quality standards (e.g., USP Monographs and General Chapters), developing policy and guidance for both brand name and generic drugs, and alleviating drug shortage situations.  
  • Participates in coordination with other OPQ components, as needed, in scientific investigations to evaluate and access any drug product quality problems that arise.

Office Organization:
These organizations report to the Office of Lifecycle Drug Products:

  • Division of Immediate & Modified Release Products I
  • Division of Immediate & Modified Release Products II
  • Division of Immediate & Modified Release Products III 
  • Division of Liquid-Based Products I
  • Division of Liquid-Based Products II
  • Division of Post-Marketing Activities I
  • Division of Post-Marketing Activities II

Office Leadership:                              
Director:  Dr. Susan Rosencrance  
Deputy Director:  Dr. Geoffrey Wu, Acting

Resources For You:

 

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