TL16: New FDA cUTI Draft Guidance and Design Implications
*Prasanna Ambati, PPD, Inc. 


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 This roundtable will discuss the different aspects of clinical trials affected by the new draft guidance.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