Talk:New Drug Application

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P1! = Phase 1 ?

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)[reply]

Add something about a rolling submission

Some companies make a rolling submission - Perhaps that could be explained in this article ? - Rod57 (talk) 11:53, 24 April 2016 (UTC)[reply]

Why not rename to New Drug Application

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]

@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)[reply]

This is about a specific process and therefore is a proper name that, according to WP:NCCAPS is capitalized. AHeneen (talk) 05:51, 1 May 2018 (UTC)[reply]

Add something about Supplemental NDAs

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]

No mention of Refusal To File

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]