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Minding the Gaps: Using Totality of Evidence in the Clinical and CMC Contexts to Support Regulatory Approval
Session Chair(s)
Alexander Varond, JD
Partner
Goodwin Procter LLP, United States
Regulatory approval dossiers often lack full evidence in areas such as clinical or CMC. Sponsors and regulators can sometimes accommodate gaps in data by utilizing a totality of evidence approach. Examples of this include the use of totality of evidence in CMC packages for botanicals and clinical packages for accelerated or conditional approval of new active substances in general. This session will dive into the concept of totality of evidence and explore recent FDA and EMA approvals that relied on totality of evidence. Attendees will learn how to distinguish between valid and questionable uses of totality of evidence and how to apply totality of evidence in their development programs.
Learning Objective : Identify how to use totality of evidence to support regulatory approval; Describe how to leverage regulatory flexibility in small or limited clinical programs; Develop strategies to overcome limitations in CMC packages, especially for botanical drug development.
Speaker(s)
Short of Perfect - Approval With Data That's Less Than Optimal
Alexander Varond, JD
Goodwin Procter LLP, United States
Partner
Clinical Evidence to Support Marketing Authorizations: Focus on Regulatory Approvals Based on a Single Pivotal Trial
Anne Morant, PHD, MSC
Anne Morant Consulting, Denmark
Regulatory Science Specialist, freelance
FDA’s Totality-of-Evidence Approach in Botanical New Drug Approval
Charles G. Wu, PHD
FDA, United States
Expert Pharmacologist, OPQ, CDER