FDA Publishes Draft Guidance on Quality Assessments

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

FDA published draft guidance on May 9, 2022 that describes the benefit-risk principles the agency applies when conducting product quality-related assessments of chemistry, manufacturing, and controls information it receives as part of new drug applications (NDAs), biologics license applications (BLAs), and supplements to drug approval applications. Data and supporting information are submitted to the agency by sponsors to demonstrate a drug product’s identity, strength, quality, and purity. FDA assesses this information to determine if 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.”

FDA considers the overall benefits and risks of the product when deciding to approve a product application. Benefit-Risk Considerations for Product Quality Assessments details how the agency assesses these risks, the sources of uncertainty, and mitigation strategies. Unresolved product quality issues, and how they may be addressed, are also discussed in the document.