Guidance Development: An Update for Statisticians
*Steve Wilson, FDA Keywords: Each year FDA publishes guidance on the development and review of new drug and biologic products. This roundtable will be an opportunity for us to learn about, think about and discuss how this new guidance (draft and final, from clinical trial design to electronic submission and review) might influence the work of industry and agency statisticians.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC