Talk:New Drug Application
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P1! = Phase 1 ? edit
Referring to the "Before Trials" section: what does 'P1' mean in the statement "typically from animal studies after P1?" Thanx.
- Phase 1 clinical trial - probably ? - Rod57 (talk) 15:59, 2 April 2022 (UTC)
Add something about a rolling submission edit
Some companies make a rolling submission - Perhaps that could be explained in this article ? - Rod57 (talk) 11:53, 24 April 2016 (UTC)
Why not rename to New Drug Application edit
Since this article is only about the US FDA procedure would it not be better to capitalise all the words ? (or is there some guideline that forbids it ?) - Rod57 (talk) 12:54, 29 July 2016 (UTC)
- @Rod57: Indeed, the FDA seems to refer to it using capital letters (example). The original title included capitals, but it was moved in 2015 to lowercase without (as far as I can tell) any discussion. I suggest moving it back to New Drug Application. Deli nk (talk) 13:26, 24 May 2017 (UTC)
Add something about Supplemental NDAs edit
As in [1]. Maybe they are for extra indications (conditions) for a drug that that has already had an NDA approved ? - Rod57 (talk) 17:06, 23 March 2018 (UTC)
No mention of Refusal To File edit
Somewhere, maybe In the actual application section, should we mention that the FDA may respond with a Refusal To File (RTF) ? - Rod57 (talk) 15:56, 2 April 2022 (UTC)