www.fdanews.com/articles/177784-fda-tweaks-guidance-on-adaptive-designs-for-device-studies
FDA Tweaks Guidance on Adaptive Designs for Device Studies
August 2, 2016
FDA has provided additional details for sponsors on how they should go about designing adaptive trials for medical devices.
The guidance makes several updates to draft guidance that was released on May 18, 2015.
The updates take into account comments the agency received that centered on definitions and particulars, but the updated guidance is not substantively changed from the draft document. — Tamra Sami