The Office of Pharmaceutical Quality Releases White Paper with Key Considerations for the Quality Overall Summary of Human Drug Applications

The Office of Pharmaceutical Quality Releases White Paper with Key Considerations for the Quality Overall Summary of Human Drug Applications The Quality Overall Summary (QOS) is a summary of all quality-related information provided by applicants to regulators in drug marketing or licensing applications, including New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs) in the United States. It is intended to condense and summarize integral quality information from a submission.  While the QOS holds great promise as a means of promoting effective communication between applicants and regulators, it has the potential to more effectively impact the efficiency and quality of regulators’ assessments across application types by addressing the disconnect that can occur between applicants and regulators regarding the communication of quality data and its impact on the assessment. This may decrease the time and/or communications (e.g., information requests) required to fully understand the quality data in an application.

The FDA is aware that some pharmaceutical companies are considering adjustments to their QOS format for upcoming submissions to improve their efficiency in the assessment process. The new white paper released by the FDA’s Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research describes key considerations for applicants when preparing a QOS. These key considerations include: Explaining product and process development in a patient-focused context Effectively summarizing the overall control strategy Guiding the regulator through the submission For more information, please contact CDER-OPQ-Inquiries@fda.hhs.gov.