Talk:Investigational New Drug
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treatment IND?
[edit]Would this article be talking the same thing as here: Treatment IND? Merge?Info different slightly? Similar? Any thoughts? Calaka (talk) 13:00, 22 April 2009 (UTC)
How many INDs this year, last year, etc.?
[edit]I have been trying to find a source for the number of IND applications received by the FDA in 2008, 2007 and so on. Also, it would be wonderful to be able to see a list of these. I have been parsing and puzzling with clinicaltrials.gov and Googling furiously. Any one have any hints? Johnfravolda (talk) 18:16, 16 July 2009 (UTC)
- 21CFR312.130 states: "The existence of an investigational new drug application will not be disclosed by FDA unless it has previously been publicly disclosed or acknowledged." [1] Therefore, no such official list exists. Tufts Center for the Study of Drug Development may have some publications that would be of interest to you [2] --Decstop (talk) 03:46, 4 September 2009 (UTC)
Are the contents of the IND kept secret forever
[edit]ie even after a subsequent NDA is approved ? - Rod57 (talk) 12:04, 24 April 2016 (UTC)
Yes, generally. Some information from the IND stage may be included in the "Action Package" that is posted a month or two after the initial NDA approval. This information would generally be minutes of meetings between the FDA and the drug Sponsor. Action Packages are posted here: https://www.accessdata.fda.gov/scripts/cder/drugsatfda/ UW.matt (talk) 14:23, 10 August 2016 (UTC)