Trial evidence and approval of therapeutic agents: In reply

摘要

Drs Green and Simon express their concern that our recent study mistook quality for quantity. The statute governing the approval of new drugs does not explicitly define the clinical trial evidence needed to obtain FDA approval. In the absence of direct guidance, the FDA uses a flexible approach to drug approval that allows the agency to weigh factors (eg, therapeutic innovation and unmet medical need) in its evidentiary requirements and subsequent approval decisions.