Talk:New chemical entity

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What makes an NCE

Article does not say if there is any formality or registration of an NCE before or distinct from say an IND application in the USA. Is there any connection with INN allocation by the WHO ? - Rod57 (talk) 10:07, 13 May 2011 (UTC)[reply]

Suspect wording

Intro says NCE is "a drug that contains no active moiety that has been approved by the FDA " - shouldn't that be "a drug that contains any active moiety that has not been approved by the FDA " ? (Moiety seem to allow a drug to have 2 active moieties - one unapproved) - Rod57 (talk) 10:15, 13 May 2011 (UTC)[reply]