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Wednesday, June 28 • 10:30am - 11:30am
25-Years After FDAMA: How is FDA Applying the Confirmatory Evidence Standard for Substantial Evidence of Effectiveness?

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Component Type: Session
Level: Intermediate

Confirmatory evidence is an under recognized path in FDA’s legal authority to approve drug marketing applications. An exploration of recent FDA actions and policy statements reveal how FDA is applying this 25-year old aspect of the law.

Learning Objectives

Discuss and analyze factors that affect applicability of the confirmatory evidence statutory standard; Recognize translational and clinical aspects of a drug development program that may have potential utility as part of a confirmatory evidence strategy.

Chair

Charles G. Raver, JD

Speakers
avatar for Charles Raver

Charles Raver

Associate Attorney, Hyman, Phelps & McNamara, PC, United States
Charles G. Raver is a food and drug law attorney who assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. His practice supports clients throughout... Read More →

Wednesday June 28, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session