When the Alpha is the Omega: P-Values, "Substantial Evidence," and the 0.05 Standard at FDA.
Kennedy-Shaffer L. When the Alpha is the Omega: P-Values, "Substantial Evidence," and the 0.05 Standard at FDA. Food And Drug Law Journal 2017, 72: 595-635. PMID: 30294197, PMCID: PMC6169785.Peer-Reviewed Original Research