FDA draft guidance on benefit-risk considerations for product quality assessments

The US Food and Drug Administration yesterday announced the availability of a draft guidance for industry,  Benefit-Risk Considerations for Product Quality Assessments.

This guidance describes the benefit-risk principles applied by the FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls information submitted for the agency assessment as part of original new drug applications (NDAs), original biologics license applications (BLAs), or supplements to those applications, in addition to other information (eg, inspectional findings) available to the 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.