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Abstract

NEW BIOLOGICAL ENTITY AND NEW CHEMICAL ENTITY SUBMISSION IN USA, JAPAN & EU

A. Lavanya*, T. Sreenivasulu, J. Praveenkumar and M. Kishorebabu

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Abstract

A new chemical entity (NCE) is, 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.[1]

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