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.
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
Director: Dr. Susan Rosencrance
Deputy Director: Dr. Geoffrey Wu, Acting
Resources For You:
- Office of Pharmaceutical Quality
- OPQ Annual Report, 2019
- Report on the State of Pharmaceutical Quality, 2019 (PDF - 793KB)
- Pharmaceutical Quality Resources
- White Paper: FDA Pharmaceutical Quality Oversight (PDF - 2.4MB)