Post-Marketing Plans: An Often-Overlooked Component of FDA Advisory Committee Meeting Discussions

This article speaks to the importance of post-approval activities as part of the discussion and voting topics that the FDA will pose to the Advisory Committee.

Preparing effectively for an FDA Advisory Committee (ADCOM) meeting requires that the sponsor team anticipate the discussion and voting topics that the FDA will pose at the ADCOM meeting. Those discussion topics and voting questions will influence the information that the team provides to the ADCOM and the questions that the ADCOM poses to the team.

To that end, we compiled and reviewed all “final questions” posed at ADCOMs from 2010 through the first half of 2015. The analysis was limited to ADCOM meetings that considered the initial approval of a drug or device, or approval of additional indications. Questions pertaining to post-approval activities, typically safety assessments, were tabulated.

This study originally appeared in Regulatory Focus. Complete the form to view our complete results.