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Tuesday, June 25 • 2:00pm - 3:15pm
#268: Current Status of FDA Framework for the Evaluation of Real World Evidence

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Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-619-L04-P; CME 1.25; IACET 1.25; RN 1.25

FDA issued a framework for a program that will evaluate the use of real world evidence (RWE) to help support the approval of new indications for an approved drug or to help support or satisfy drug post approval study requirements. During this session, FDA will share their takeaways from public comments about the RWE framework and provide participants with an update on the current status of the FDA RWE Program.

Learning Objectives

Identify three topic areas included in the FDA real world evidence program; Identify and discuss two FDA takeaways from the analysis of public comments to the real world evidence framework; Identify one area of interest for real world evidence guidance development.


M. Khair ElZarrad, PhD, MPH


FDA Update
Jacqueline A. Corrigan-Curay, JD, MD

Update from CBER
Steven A. Anderson, PhD

FDA Update
David Martin, MD, MPH

avatar for M. Khair ElZarrad

M. Khair ElZarrad

Deputy Director, Office of Medical Policy, CDER, FDA
Dr. ElZarrad is the Deputy Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads... Read More →
avatar for Steven Anderson

Steven Anderson

Director, Office of Biostatistics and Epidemiology, CBER, FDA
Steven Anderson, Ph.D., M.P.P., is currently the Director of the Office of Biostatistics and Epidemiology (OBE) at the FDA Center for Biologics Evaluation and Research (CBER). He provides leadership for all CBER statistical, epidemiological and risk assessment programs. He was previously... Read More →
avatar for Jacqueline Corrigan-Curay

Jacqueline Corrigan-Curay

Director, Office of Medical Policy, CDER, FDA
Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay... Read More →
avatar for David Martin

David Martin

Associate Director for Real World Evidence Analytics, OMP, CDER, FDA
David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions... Read More →

Tuesday June 25, 2019 2:00pm - 3:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session