Postmarketing Plans: An Often Overlooked Component of FDA Advisory Committee Meeting Discussions
Preparing effectively for an FDA Advisory Committee meeting requires that the Sponsor team anticipate the discussion and voting topics that the FDA will pose to the Advisory Committee. Those discussion topics and voting questions will influence the information that the team provides to the committee and the questions that the committee poses to the team.
To that end, we compiled and reviewed all “Final Questions” posed by the FDA to Advisory Committees from 2010 through the first half of 2015. The analysis was limited to Advisory Committee 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.
ABOUT THE AUTHOR
Christen M. Anderson, M.D., Ph.D., FTOS, is a biotechnology/pharmaceutical consultant at 3D Communications www.3dcom.brinkdev.com with over 25 years experience in all phases of drug development. With a background in endocrinology and metabolism, Dr. Anderson assists 3D’s clients with pre-submission strategic planning and post-submission Advisory Committee preparation. She also assists clients with clinical development strategy, trial design and interpretation and data analyses. Throughout her academic and biotech careers, she has published extensively in peer-reviewed journals. Connect with Dr. Anderson through LinkedIn.
Acknowledgements: The author thanks Karen Johnson and Allison Dail for invaluable assistance compiling the information for this article, and Dr. Lara Burgess for editorial review.