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FDA以药品的化学类型和潜在利益为基础 ,将新药申请分为研究用新药申请 ( investigational new drug applica-tions,INDs)和新药申请 ( new drug applications,NDAs)以确定审评的优先权。化学类型 ( Chemical Type,CHE)1 .新分子实体 ( New molecular entity,NME) :一种从未在
Based on the chemical type and potential benefit of the drug, the FDA divides new drug applications into INDs and new drug applications (NDAs) to prioritize reviews. Chemical Type (CHE) 1. New Molecular Entity (NME)