camres-ga,
The following site has a comprehensive list of downloadable forms for
Investigational Drugs.
The US Food and Drug Application Process website:
http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm
The above site links to this page,
http://forms.psc.gov/forms/FDA/fda.html
where you can download over 40 different forms from the FDA. All the
forms are in Adobe format, and you will need a reader installed on
your computer. The site above has a link near the top of the page, to
Adobe, where you can download a free reader.
It appears to me that you are probably asking for one of the two forms
I have listed:
“ Application to Market a New Drug, Biologic, or An Antibiotic Drug
For Human Use” FDA-356h , the first form on the list
or
“Investigational New Drug Application” FDA-1571, is the seventh form
on the list.
Both of the above forms were recently updated (September 2002)
Another governmental site with forms and information about the forms
and regulations can be found here:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312
More rules and regulations about the Investigational New Drug
Application
http://www.fda.gov/cder/forms/1571-1572-help.html
New drug development process
http://www.fda.gov/cder/handbook/dev_rev.htm
Drug Review glossary:
http://www.fda.gov/fdac/special/newdrug/bengloss.html
From the Office of New Animal Drug Evaluation (ONADE) website (in case
you are doing veterinary work)
http://www.fda.gov/cvm/aboutcvm/aboutona.htm
I hope I have interpreted your request correctly, and supplied you
with the appropriate links to the forms you need. If you have any
further requests, or any part of my answer is not clear, please ask
for an answer clarification.
Regards,
crabcakes |
Clarification of Answer by
crabcakes-ga
on
19 Oct 2002 14:07 PDT
camres,
I am sorry I did not understand that you wanted an IND that was
already completely filled out and I wish I had known you already had
the information I gave you, so you could have gotten your answer
sooner as well.
I have done numerous searches looking for a copy of a "filled-in"
application, using these search terms;
Approved investigational drug applications
Completed investigational drug applications
Examples investigational drug applications
and came up with nothing. While probably not <impossible>, it is
unlikely that an IND that has been comleted and approved will be found
online. The information contained on INDs is generally classified and
proprietary. Pharmaceutical companies take every precaution in
maintaining secrecy when it comes to a potentially marketable and
profitable new drug!
You may certainly request a refund from the Google Editors, thereby
freeing this question for another researcher who may be able to find
what you are requesting.
Regards,
crabcakes
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