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organiccooker金虫 (正式写手)
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[交流]
快来看FDA对化药分类代码的意义，特别是Orphan drug 是什么意义，千万别望文生义哦！ 已有2人参与
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What do the Chemical Type and Review Classification codes stand for? NDA Chemical Types Number Meaning 1 New molecular entity (NME) 2 New active ingredient 3 New dosage form 4 New combination 5 New formulation or new manufacturer 6 New indication 7 Drug already marketed without an approved NDA 8 OTC (over-the-counter) switch 10 New indication submitted as distinct NDA - not consolidated Review Classifications Letter Meaning P Priority review drug: A drug that appears to represent an advance over available therapy S Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug O Orphan drug - a product that treats a rare disease affecting fewer than 200,000 Americans 个人感觉信息量虽小，却很有意义！ 给点鼓励哦 |
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3楼2018-10-26 10:46:54