Statistics and Drug Regulation in the US: Where We’ve Been and Where We Are Today
*Lisa LaVange, FDA/CDER Keywords: In this 175th year of the ASA, a reflection on the importance of statistics in US drug regulation is timely. I will look back to the early days of the FDA and describe the evolution of biostatistics as a discipline in the Center for Drug Evaluation and Research (CDER). The growth of biostatistics in size -- from a single CDER division to an office of over 170 employees, and in mission --from a group focused on fundamental concepts of clinical trials to a group now engaged in numerous and varied aspects of drug development and both pre- and post-market regulation, will be chronicled. Moving to the present day, I will give a broad overview of the statistical issues and review challenges we face now. Areas that hold opportunity for statisticians to provide innovation and play a leadership role in drug regulation in the future will be highlighted.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC