Posted By
Amit Jain
07-Sep-2018 11:07
Found In
Egroup:
Regulatory Open Forum
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New chemical entity (NCE) is, according to the US FDA, a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act A new molecular entity (NME) is a drug that contains an active moiety that ...
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