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金虫 (正式写手)

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注册: 2007-03-04
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专业: 合成药物化学

[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

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！
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