On February 25, 2016, FDA held a workshop on "Next Generation Sequencing-Based Oncology Panels," agency web page for this meeting, here. The FDA posted an 8 page discussion paper for the meeting, here.
FDA also compiled the slide decks presented as one 200 page, 8 mb file (here). The video webcast is archived on line (here). Update: Unofficial transcript in the cloud, here.
The agency accepted written public comment until March 28, 2016. The agenda is posted below the break.
For those with subscription, detailed coverage from Genomeweb of the 2016 workshop, here. FDA personalized medicine leader Elizabeth Mansfield is quoted as stating: "We think panels are a really great way to move forward in oncology where you can get all the information you need out of one test … FDA actually supports this idea." For additional subscription coverage, at Gray Sheet, here.
The conference follows last year's February 2015 workshop on NGS diagnostic tests in general (webpage here, which includes archival decks and transcript.)
Note: On a related topic, see the open access Goldfeder et al. article the same week in Genome Medicine on interlaboratory standards and accuracy of NGS (here).
Note: The FDA also held a workshop a few days later on "Patient and Medical Professional Perspectives on the Return of Genetic Test Results," March 2, 2016, here.