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new
/njuː/
chemical
/ˈkɛmɪkəl/
entity
/ˈɛntɪti/
Description
new chemical entity    according to the U.S. Food and Drug Administration, 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

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