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The following message was posted to: PharmPK
[A response to "Males vs females" - db]
I'm glad that Nick commented on the publically available information.
[New thread - db]
I know that someone asked if I would comment, however, there are very
limitations on discussing sponsor's data and I would need to have
say go through an approval process first.
I would also like to expand on this and change the thread.
Frequently, individuals post questions regarding regulatory issues.
the answers will depend on the individual country and their regulations,
which are not always given.
In general the questioner should first see if there is a written
from the agency on their web site that addresses the question.
If there are still questions there is frequently not sufficient
provided in the e-mail to answer.
N.B. The individuals who answer on PharmPK frequently provide incorrect
Except for inexperienced reviewers, people from agencies are unlikely to
answer on PharmPK for several reasons including:
a) There is insufficient information.
b) Any answer could be binding on an agency.
c) All answers need to be vetted internally and approved by the
agency's management for regulatory and scientific accuracy,
wider regulatory implications.
d) There needs to be internal documentation and tracking of all
responses (see b above).
If you do submit questions to an agency please note the following:
Ask specific questions, not generalities.
Include all relevant background information for the specific
situation. Part of this should include why are you asking the question.
Provide what you think you should do.
Provide a detailed justification for what you think you should do.
Include assumptions, data, etc.
If there are alternatives discuss them along with what made you
reject them as being scientifically undesirable.
Don't ask the same question over and over again with the same or
nearly the same data. If you don't like the answer for business
may need to reevaluate if the drug is worth pursuing, or if additional
In my experience the reason for multiple NDA review cycles is typically
quality and incomplete submissions due to rushing to submit before
completed adequate studies to address the pertinent questions. I
think that taking an extra day or two to think about data at critical
junctions or taking an extra 3 months to put together a better
would result in an approval on the first review cycle instead of on the
second or even third.
Note - We hate do you agree questions with little or no data or
justification. This includes only mean data. The answer is almost
that's a review issue, i.e. when we see some data and know what we're
actually talking about and can think about it and discuss it internally
we'll know how to answer.
Lastly, in a previous life I worked in regulatory affairs for a major
company and in my experience although FDA is the 800 lb. gorilla due to
size, resources, as well as the size of the US market. There are some
excellent scientists in regulatory agencies worldwide and I'm not just
talking about the 'major' agencies such as US, Japan, EU, but rather
the smaller agencies in South America, Asia, etc..
Just as we get good and bad submissions from the same company depending
who the individuals who did the science or prepared the submission are,
which agency does the best review work will depend on the individual
reviewers who work on the submission.
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