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Suggestions for Improving
"Controlled Correspondence" to the Office of Generic
Drugs.
The Office of Generic Drugs (OGD) is very willing to provide
assistance to pharmaceutical firms and related industry regarding a
variety of questions posed as "controlled documents." It
is important to realize, however, that these questions must be
answered by the same reviewers that are expected to review the
abbreviated new drug applications (ANDAs). With the expectations
from Congress, the Commissioner and the industry regarding
timeliness of review, responses to the requests take much longer
than OGD would like. As an aside, OGD expects to be able to make
dissolution information available on the internet sometime soon. A
common request is for dissolution information. When the information
is freely available, there should be a decrease in requests.
OGD has some suggestions that might help everyone to get
appropriate questions answered in a timely manner while still
getting reviews done. If anyone has other thoughts, OGD is willing
to listen.
- Please do your homework before sending a control. Most of the
time, it is obvious that the requestor has researched an issue
prior to submitting a control. But this is not always the case.
For example, instead of asking for the bioequivalence protocol
for a product, research the issue, draft a protocol and send it
in for comment. This helps everyone.
- Please don’t submit multiple copies of the same questions to
different people. If the duplicate is not recognized, time is
wasted later trying to reconcile the requests or even wasted
with duplicate reviews.
- Submit requests for multiple products separately. Different
reviewers or staff may be able to answer requests about one drug
but not another. Also, some issues are more complex, requiring
more time to answer, than others. This will delay the response
to the entire request. It may increase the number of incoming
documents, but the documents can be processed more efficiently
if submitted separately.
- Try to clearly mark submissions as controlled correspondence
to differentiate them from a submission to an ANDA. All too
frequently, a requestor calls to check on the status of a
controlled document and it is discovered marked as "new
correspondence" to the ANDA.
- Be clear in the request and include all pertinent information.
Some responses are not timely or not complete because the
reviewer has to guess as to what is being asked and may not have
enough information available to fully assess the issue.
- OGD does want to help firms and contract research
organizations but these groups must be reasonable in their
expectations. If there are a number of products for which
information is sought, we suggest that the request be
prioritized in order to receive timely responses.
- Be sure that the question to be asked is not more
appropriately submitted to an ANDA. Some controlled requests are
really review issues for applications and serve to bog down the
system.
OGD wants to assist the industry through controlled
correspondence but to be effective, the system should not be abused
or overused.
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Date created: August 27, 2003 |
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