The US Food and Drug Administration (FDA) has issued draft guidance outlining its benefit-risk principles when evaluating product quality assessments for new drug applications (NDA), biologics license applications (BLAs), and supplements.
The draft guidance, released on 10 May, provides details on possible mitigation strategies for quality issues and the circumstances under which unresolved quality issues could be addressed during a public health emergency or widespread drug shortage.
When looking at product quality assessment of marketing applications, FDA considers the interplay between therapeutic context, potential benefits, and quality-related risk considerations…
