FDA Guidance for Industry: Benefit-Risk Considerations for Product Quality Assessments
Titel:
FDA Guidance for Industry: Benefit-Risk Considerations for Product Quality Assessments
Internet:
Herkunft/Verlag:
FDA
Inhalt:
This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls (CMC)2 information submitted for FDA assessment