Talk:Investigational New Drug

From Wikipedia, the free encyclopedia
Jump to: navigation, search
WikiProject Pharmacology (Rated Start-class, Mid-importance)
WikiProject icon This article is within the scope of WikiProject Pharmacology, a collaborative effort to improve the coverage of Pharmacology on Wikipedia. If you would like to participate, please visit the project page, where you can join the discussion and see a list of open tasks.
Start-Class article Start  This article has been rated as Start-Class on the project's quality scale.
 Mid  This article has been rated as Mid-importance on the project's importance scale.

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 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: UW.matt (talk) 14:23, 10 August 2016 (UTC)

What costs or fees relate to an IND application[edit]

? - Rod57 (talk) 12:04, 24 April 2016 (UTC)