FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Offers Recommendations on Quality Overall Summaries

Jan. 26, 2018
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Drugmakers seeking to streamline their Quality Overall Summary (QOS) should identify the main risks from a product quality perspective and how the proposed strategy mitigates the risks to the patient, according to a new white paper from the FDA’s Office of Pharmaceutical Quality.

To create an effective QOS, applicants should ensure it explains the product and its development from a patient-focused perspective, guides the regulatory body through a submission and adequately sums up the overall control strategy, OPQ said.

Sponsors are not getting the most out of their QOS, according to the OPQ, and disparate regional expectations limit their effectiveness.

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