Drugs

Considerations for Quality Overall Summary

An FDA white paper, “A Regulatory Perspective on the Quality Overall Summary (QOS): Putting the Pieces Together,” defines the QOS as a summary of all quality-related information provided by applicants to regulators in drug marketing or licensing applications, including NDAs, ANDAs, and BLAs in the U.S. It is intended to condense and summarize integral quality information from the submission in a transparent manner.

The paper says the QOS could substantially decrease the effort needed by regulators to understand, summarize, collate, and interpret quality-related data in an application. The document describes key considerations when creating a QOS that:

explains product and process development in a patient-focused context;
effectively summarizes the overall control strategy; and
guides the regulator through the submission.

“Ideally,” the agency says, “the regulator should be able to use the QOS to initiate the assessment of potential risk to the patient, and the control of such risk, in the commercially manufactured product. An effective QOS can benefit applicants and regulators by improving communication and transparency, but also emphasizes the direct link of quality to patients by specifically focusing on a product’s overall control strategy, potential risk factors related to quality, and other benefit/risk considerations.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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