TL16: New FDA cUTI Draft Guidance and Design Implications
*Prasanna Ambati, PPD, Inc. Keywords: The thought process which went into this guidance have been incorporated into the study design in past few years, so there is some accumulated experience which will aid the discussion. This roundtable will discuss the different aspects of clinical trials affected by the new draft guidance. The topics to be considered include: 1. Changes from the existing practice 2. Impact on designing new studies 3. Impact on ongoing studies 4. Experience based on recent trial development from interactions with FDA
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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