关注FDA网站的看过来，请教个问题哈？1.新分子实体 2.新活性成分 3.新机型 4.新组合物 5.新生产厂家 6.新适应症 7.已上市却无批准的NDA（一些很老的药物，FDA有解释1 - First post-1962 applications for products marketed prior to 1938；2 - First applications for DESI-related products first marketed between 1938 and 1962 without NDAs；3 - First applications for DESI-related products first marketed after 1962 without NDAs - The indications can be the same or different from the legally marketed product） 8.处方药转OTC（不知是否是 prescription OTC switch？ FDA的解释：1.These NDAs are not true switches since these products were marketed as prescription products without an approved NDA prior to being approved for OTC marketing under an NDA; 2.These NDAs are not true switches since the conditions of use were not marketed as a prescription product under an approved NDA prior to being approved for marketing OTC. ） 10.这一类药，本人也弄得不是很明白，但是我找到个实例——拜耳的REGORAFENIB（NDA:204-369就是这一类）你自己深入研究吧，我是做制剂的，了解一下就算了，呵呵查看更多
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