2012?7?9?,??????????�??????????�(Generic Drug User Fee Amendments, GDUFA)?????????????,????FDA??????????GMP???????,?????????API?????FDA??????????????????????????,???????????:
1??????????????????II?API??????FDA???????? (Self-identification),2013??????????????2012?12?3?,??2??2012?12?17????
2????2012?10?1??????,?2012?10?1??????????? (Abbreviated New Drug Application, ANDA) ??2012?11?23????$17,434?
3????2012?10?1?? 2013?9?30??????ANDA???$51,520,???????? (Prior Approval Supplement, PAS) ???$25,760?
4????2012?10?1??2013?9?30??????ANDA???????????????? (Drug Master File,DMF) ??????$21,340?API????????DMF????ANDA??????????,??????????
5?FDA??????DMF????????? (Completeness Assessment),????????DMF?????? FDA???????????FDA???????ANDA????????DMF??????? (Full Review)?
6???ANDA????/????ANDA???API??????FDA????? (Facility Fee)?2013????????????2013?1?13???????????????????????????????,?????????? FDA???GMP?????
7???????????????
8????????????????????