the discussion involves any other products or fillers not already on the agenda for which
the FDA participant has a personal or imputed financial interest, the participants need to
exclude themselves from such involvement and their exclusion will be noted for the
With respect to FDA’s industry representative, we would like to disclose
that Dr. Rick Veltri is serving as the non-voting industry representative, acting on behalf
Scribes, LLC Toll Free 1-800-675-8846 www.scribesllc.com
Based on the agenda for today’s meeting all financial interests reported
by the Committee members and temporary voting members it has been determined that
our interests in firms regulated by the Center for Drug Evaluation and Research present
of our regulated industry. Dr. Veltri’s role at this meeting is to represent industry in
general and not any one particular company. Dr. Veltri is employed by Schering-Plough.
no potential for conflict of interest.
We would like to remind members and temporary voting members that if
meeting is open for public observation, public attendees may not participate, except at the
specific request of the panel.
FDA encourages all the participants to advise the Committee of any
financial relationships that they may have with any firms at issue. Thank you.
DR. BURMAN: Eric, good morning. We just introduced ourselves and
maybe, would you be kind enough to do that as well?
I would like to remind public observers at this meeting that while this
DR. FELNER: My name is Eric Felner. I’m a Pediatric Endocrinologist
at Emory University.
DR. BURMAN: Thank you. We will now proceed with our first
presentation from the FDA by Dr. Hylton Joffe.