15/16 November 2023
Before approving an application, the FDA must determine whether the drug product is both safe and effective for use under the conditions prescribed, according to the product labeling and the instructions it contains. The applicant must demonstrate that development studies, manufacturing process, and control strategy will consistently result in a finished product of acceptable quality when manufactured at the facilities named in the application.
When determining whether a drug or biological product meets the standard for approval, the agency conducts an overall benefit-risk assessment (see also FDA’s Benefit-Risk Framework). The draft guidance therefore describes the FDA principles when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information in addition to other available information (e.g., inspectional findings).
During the product quality assessment, assessors may use the interdisciplinary team’s understanding of the therapeutic context and the assessment of benefit to:
Although each application will contain unique information on CMC strategies, FDA routinely applies the following principles when evaluating quality issues during its assessment:
At the end of the assessment, the product quality assessment team provides its recommendation to approve or not approve a marketing application. The agency will usually not approve the application when unresolved quality issues remain. However, in rare circumstances, an application may meet the standard for approval despite the presence of certain unresolved quality issues. Examples could include cases where it is not feasible for the product quality issue to be resolved before approval and it can be addressed post-approval without an unacceptable level of risk (e.g., providing post-approval confirmatory photostability data to address a change in film-coat composition that affects shading of film-coat color).
More information is provided in FDA´s draft Guidance for Industry Benefit-Risk Considerations for Product Quality Assessments.