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FREQUENTLY
ASKED QUESTIONS
Q. Who
is required to
submit an IND?
A. The IND is a
requirement for all
persons and firms
seeking to ship
unapproved drugs
across state lines for
use in clinical
investigations.
However, the FDA
does offer exemptions
from IND submission
requirements for
certain types of
clinical testing on
products.
Q. Is
the new EU
Clinical Trial
Directive now in
effect?
A. The New EU
Clinical Trial
Directive became
effective as of May,
2004.
Q.
Throughout the NDA
Review Process, as
sponsor, can I
request meetings
with the reviewing
team?
A. Depending on the
drug, the sponsor may
be eligible throughout
the NDA review process
to request various
meetings with the
reviewing team.
Optionally,
these meetings can be
conducted by
videoconference,
teleconference, or
face-to-face.
Q.
How do I keep
abreast of current
trends in
regulatory affairs
in the European
Union?
A. To keep
abreast of the current
RA trends in the EU,
log on to the
following website:
Q.
How do I keep
abreast of current
trends in US or
other country
regulatory
information?
A. To keep
abreast of the current
RA trends in the US
and other countries,
click on useful links
on this website and it
will take you directly
to the websites for US
FDA and other
countries in Europe,
Asia/Oceania,
Americas, Africa, and
the Middle East.
Other useful
links for regulatory
information such as
RAPS, DIA, WHO &
ICH are also provided.
Q.
How can I obtain
translation of
regulatory
information?
A. Translation of
regulatory and other
information obtained
from this website is
available. This can be
obtained by clicking
on the appropriate
language from the
pulldown menu on the
bottom of each page.
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