- FDA's Office of Pharmaceutical Quality (OPQ) outlined key considerations drug companies should include when preparing a Quality Overall Summary (QOS) as part of certain human drug applications in a new white paper this week.
- The agency said that the white paper comes in response to pharmaceutical companies that are "considering adjustments to their QOS format for upcoming submissions to improve their efficiency in the assessment process."
- QOS, which contains a summary of quality-related information provided by applicants, aims to improve communication between the agency and drug companies and reduce the time needed for FDA to understand the quality data.
The white paper comes as OPQ develops a common informatics platform to better align patient needs with drug risks when making recommendations for application submissions of small molecules as well as biologics, and generic drugs.
The key considerations FDA says sponsors should include in a QOS include:
- Making sure product and process development is explained in a patient-focused context.
- Effectively describing the overall control strategy.
- Ensuring FDA is guided through the application 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," FDA said in a statement.
The agency says that one approach to make QOS more effective is to use a question-based review QOS for generic drug applications. But as applicants explore alternative formats for applications to better align QOS across multiple global regions, FDA notes that a regulator should be able use the QOS to "initiate the assessment of potential risk to the patient, and the control of such risk, in the commercially manufactured product."
"For example, QOS content could provide regulators with an opportunity to better and more quickly understand a product’s overall benefit-risk profile and overall control strategy from a quality perspective, given the indication(s), patient population, and intended use. The QOS could provide an initial orientation to the measures taken to mitigate or control risk to the patient," the white paper states.
Better use of QOS, if properly used to improve application assessments, "should lead to improved access" to safe and effective drugs, the white paper says. That goal falls in line with FDA Commissioner Scott Gottlieb's efforts to speed drug reviews and improve regulatory processes, which is leading to increased competition in the marketplace and potentially could help lower drug prices.