The draft guidance outlines the benefit-risk principles used to perform product quality-related assessments of CMC information submitted to the FDA for evaluation under NDAs, BLAs, or supplements.
The FDA released draft guidance on May 9, 2022 that outlines benefit-risk principles the agency applies when performing quality-related assessments of chemicals, manufacturing, and quality control information. She receives for New Drug Applications (NDAs), Biologics License Applications (BLAs) and Supplemental Drug Approval Applications. Data and supporting information are submitted to the agency by sponsors to demonstrate the identity, strength, quality, and purity of a pharmaceutical product. The FDA evaluates this information to determine whether “an applicant’s product 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. “.
The FDA considers the overall benefits and risks of the product when deciding whether to approve a product application. Benefit-Risk Considerations for Product Quality Assessments details how the agency assesses these risks, sources of uncertainty and mitigation strategies. Unresolved product quality issues and how they can be resolved are also discussed in the document.