Introduction to FDA's"Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence Guidance for Industry"
"If[FDA]determines,based on relevant science,that data from one adequate and well-controlled clinical investigation and confirmatory evidence are sufficient to establish effectiveness,[FDA]may consider such data and evidence to constitute substantial evidence."Although the Food and Drug Administration(FDA)'s evidentiary standard for effectiveness has not changed since 1998,drug development and science have continued to evolve,leading to changes in the nature of drug development programs,more guidances need to be provided to clarify the flexibility of this standard.To meet this demand,FDA released the"Demonstrating Substantial Evidence of Effectiveness With One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence Draft Guidance for Industry"in September 2023,supplementing the FDA's 2019 Effectiveness draft guidance and 1998 Effectiveness guidance.This guidance describes factors to consider when assessing whether a single adequate and well-controlled clinical investigation and confirmatory evidence are sufficient to demonstrate substantial evidence of effectiveness,and also provides examples of the data types of confirmatory evidence.There is currently no similar guidance in our country.This article provides a detailed introduction to the FDA's guidance,hoping to be beneficial for research and regulation in this area in China.
Food and Drug Administration(FDA)clinical investigationconfirmatory evidencesubstantial evidence of effectivenessguidance
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