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Referring to the "Before Trials" section: what does 'P1' mean in the statement "typically from animal studies after P1?" Thanx.
Some companies make a rolling submission - Perhaps that could be explained in this article ? - Rod57 (talk) 11:53, 24 April 2016 (UTC)Reply
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)Reply
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)Reply
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)Reply