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Food and Drug Law Journal|April 26, 2018
FDA's Flexibility in Subpart H Approvals: Assessing Quantum of Effectiveness EvidenceFrank J Sasinowski, Alexander J VarondTherapeutic Innovation & Regulatory Science|December 10, 2020
Single-Study Approvals: Quantum of Evidence RequiredFrank J Sasinowski, Michelle L ButlerTherapeutic Innovation & Regulatory Science|September 28, 2019
Single-Study Approvals: Quantum of Evidence RequiredFrank J Sasinowski, Michelle L ButlerTherapeutic Innovation & Regulatory Science|September 19, 2018
Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs: Update, July 2010 to June 2014Frank J Sasinowski, Erika B Panico, James E ValentinePageof 1