A Regulatory Perspective on the Quality Overall Summary: Putting the Pieces Together

The Quality Overall Summary (QOS) is an element of a drug marketing application that provides a substantially condensed summary of the quality-related data provided in the submission. Regulators can use the QOS to more effectively assess applications and more rapidly comprehend the quality information in the context of patient risk, including the proposed control strategy and any other planned steps to mitigate that risk. Patients benefit from the greater assessment efficiency by having improved access to drugs that are designed and manufactured to consistently and safely fulfill claims in the label.

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