EW SHOW DAILY
40
ASCRS Symposia
by Ellen Stodola EyeWorld Senior Staff Writer
Monday, April 16, 2018
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on to discuss the changing drug
development and regulatory land-
scape, the 2017 year in review, and
modernization efforts for the new
drug regulatory review program.
He noted that prior to 1938, the
FDA could only respond to prob-
lems. Companies were permitted to
market; there were no requirements
for testing or approval; and the
government could seek to remove
dangerous or misbranded products.
The Food, Drug, and Cosmet-
ic Act of 1938 added pre-market
notification, and an approved new
drug application was now required,
but marketing could proceed after
6 months if no action was taken by
the FDA.
Dr. Stein highlighted the
changing landscape in drug develop-
ment and drug regulation at CDER,
mentioning that there are more
programs targeting rare disease and
fewer large development programs
A
symposium sponsored by
the ASCRS FDA Commit-
tee on Sunday afternoon
focused on "Accelerating
Drug and Device Inno-
vation: FDA's Reorganization and
Overhaul of the Regulatory Review
Process to Bring Innovative and
Effective Products to Market."
Natalie Afshari, MD, San Di-
ego, moderated the session, which
also included Malvina Eydelman,
MD, Division of Ophthalmic and
Ear, Nose and Throat Device, U.S.
Food and Drug Administration
(FDA) Center for Devices and
Radiological Health (CDRH), Silver
Spring, Maryland, and Peter Stein,
MD, deputy director, Office of New
Drugs (OND), FDA Center for Drug
Evaluation and Research (CDER),
Silver Spring, Maryland.
Dr. Stein first highlighted the
regulatory evolution of the FDA
from 1906 to today before moving
Symposium focuses on accelerating drug and
device innovation and FDA reorganization
Dr. Stein discusses the changing drug development and regulatory landscape during the FDA
symposium.
