REGULATORY UPDATE: New FDA Guidance Addresses Benefit-Risk Considerations for Product Quality Assessments

The Food and Drug Administration released a new draft guidance last Tuesday that describes the benefit-risk principles applied by the agency when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC) information submitted for FDA assessment as part of original new drug applications (NDAs) under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), original biologics license applications (BLAs) under section 351 of the Public Health Service Act (PHS Act), or supplements to such applications.

This guidance discusses how FDA assesses risks, sources of uncertainty and possible mitigation strategies for a product quality-related issue and how those considerations inform FDA’s understanding of the potential effect on a product. The guidance also discusses how unresolved product quality issues may be addressed in the context of regulatory decision-making.

AABB is reviewing the draft guidance to determine the need for comments. Members interesting in submitting comments may send them to regulatory@aabb.org. FDA is accepting comments through July 10.