Talk:Investigational New Drug
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treatment IND?
editWould 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.?
editI 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." 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 --Decstop (talk) 03:46, 4 September 2009 (UTC)
Are the contents of the IND kept secret forever
editie 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)