Location: \;
\nFDA White Oak Campus
\n10903 New Hampshire Avenue
\nBuilding 3
1\, Room 1503 (Great Room)
\nSilver Spring\, MD 20993
\n(Informa
tion about arrival to \;FDA&r
squo\;s White Oak campus)
\n
\nOn March 20th\, FDA is conduc
ting a public workshop to discuss the use of complex innovative designs (C
ID) in clinical trials of drugs and biological products to inform regulato
ry decision making. \;
\n
\nThis meeting will inform develop
ment of a guidance document as required by the 21st Century Cures Act (Cur
es Act) and is being conducted to meet the performance goal of convening a
public workshop on CID included in the sixth authorization of the Prescri
ption Drug User Fee Act (PDUFA VI)\, part of the FDA Reauthorization Act (
FDARA). \; This meeting will also inform the development of a CID pilo
t program. \; \;
\n
\nThe purpose of this public meeting
is to:
\n
\n1. Facilitate discussion and information sharing ab
out the use of CID in drug development and regulatory decision making
\n
\n2. Obtain input from stakeholders about the CID pilot program.<
br />\n
\nFDA is seeking information and comments from a broad range
of stakeholders. \;
\n
\nRegistration:&n
bsp\;
\nTo register for this meeting\, visit: \;https://complexinnovativedesigns
.eventbrite.com/
\n
\nRegistration for in-person attendance
will close on March 13\, 2018.
\n
\nIf you are unable to attend
the workshop in person\, you can register to view a live webcast of the wo
rkshop. You will be asked to indicate in your registration if you plan to
attend in person or via the webcast. Seating will be limited\, so early re
gistration is recommended. Registration is free and will be on a first-com
e\, first-served basis. However\, FDA may limit the number of participants
from each organization based on space limitations.
\n
\nWebcast:
\nComplex Innovative Designs Public Meeting- March
2018
\nThe webcast will begin streaming approximately one-half
hour before the start of the meeting. A recording of the webcast as well a
s a transcript will be available on this meeting website approximately one
month after the meeting takes place.
\n
\nFor more details plea
se click here
.
END:VEVENT
END:VCALENDAR