This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls information submitted for FDA assessment as part of original new drug applications (NDAs), original biologics license applications (BLAs), or supplements to those applications, in addition to other information (e.g., inspectional findings) available to FDA during its assessment.
Applicants submit data and supporting information to demonstrate they can ensure and preserve a drug product’s identity, strength, quality, and purity for NDAs or a biological product’s safety, purity, and potency for BLAs. The product quality assessment determines 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. When a regulatory decision regarding the approval of an NDA or BLA is made, FDA considers the overall benefit(s) and risk(s) identified for the product, including any residual risk related to unresolved product quality issues. This guidance discusses how FDA assesses risks, sources of uncertainty, and possible mitigation strategies for product quality-related issues and how those considerations inform FDA’s understanding of the potential effect on a product. This guidance also discusses how unresolved product quality issues may be addressed in the context of regulatory decision-making. [FDA]