31
EW SHOW DAILY
ASCRS•ASOA Symposium & Congress, San Diego 2015
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by Vanessa Caceres EyeWorld Contributing Writer
be moderated by Natalie A. Afshari,
MD, FACS. It will be held on Sunday
from 8:00–9:30 a.m. in room 6D
of the San Diego Convention
Center. EW G
et an update on U.S. Food
and Drug Administration
(FDA)-related news that
affects ophthalmology at
the Sunday symposium
"Current FDA Hot Topics: Update
on Drug Compounding and Drug
and Device Approval Updates."
This symposium will be
comprised of 2 panels: "Drug
Compounding and its Impact on
Ophthalmology" and the "Drug
and Device Approval Process."
The "Drug Compounding and
its Impact on Ophthalmology"
portion of the symposium will focus
on the key issues affecting ophthal-
mology that relate to the recent
enactment of the Drug Quality and
Security Act, such as office use of
compounded drugs and continued
access to repackaged drugs. Panel-
ists will discuss the FDA's recently
released drug compounding guid-
ance for both 503A traditional
compounders and 503B outsourcing
facilities, which permits compound-
ing pharmacies to repackage biologic
products, such as Avastin (bevaci-
zumab, Genentech, South San Fran-
cisco). There are concerns regarding
the proposed beyond-use date for
Avastin, which the panelists will also
discuss. Panelists will review the im-
pact these new regulations have had
and will have on ophthalmic prac-
tices. The panelists will be Charles
Leiter, PharmD, CEO and president
of Leiter's Compounding Pharmacy;
and Mark L. Baum, CEO of Imprimis
Pharmaceuticals.
The second part of the sym-
posium will be "Drug and Device
Approval Process." This panel will
discuss the current 21st Century
Cures Initiative led by the U.S.
House of Representatives Energy and
Commerce Committee, with a focus
on the expedited approval of drugs
and devices in the United States.
Panelists from the FDA will address
what the FDA has been doing and
what they are planning to do in the
future to make the drug and device
approval process more efficient.
Panelists will be Wiley Chambers II,
MD, deputy director of the Division
of Transplant and Ophthalmology
Products, Center for Drug Evaluation
and Research, FDA; and Malvina B.
Eydelman, MD, director of the
Division of Ophthalmic and Ear,
Nose and Throat Devices, FDA.
The symposium is sponsored by
the ASCRS FDA Committee and will
FDA symposium to cover drug
compounding, drug approval
