????????????????????????????
?????????????????????????????????????????????6?29??30??????????4?29??TOPICS??????????????????????FDA??????working group????????????????????????????????????????????????????????????MEMORANDUM??????????27????????
?MEMORANDUM?FDA Briefing Material??PDF:6.84MB??BRIEFING INFORMATION?
?????????????????????OTC????????????????????????????????
- ????????????????????????????????????
- ???????????????????????
?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????3?????????????????????????????????????????????????????????????? - ?????????3250mg????4000mg??????????????3???????????????????
- 1?????????325mg?????????????????650mg????1000mg?????
- ??????????
?160mg/5ml??????????????????????2??????? - ?????????
- ????????????????????????
??????????????????????
- ????????????OTC????
- ?????????
????????????OTC???????????????????????????????????Medication Guide?????? - ??????????????
- OTC?????????????????
?????????????????????????????????????????????????
- 500????????????????????
- OTC???????????????????????
?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????NSAIDS?????????????? - ???????????
- ??????????????
- ??????????APAP???????????????????????
??????????????????????????????????????????????????????????????????????????????????????????????????
?http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4429b1-01-FDA.pdf
- ??????1?325mg?1???650mg??????????????????????
- ??????????????
- ????????????????1?????????????
?????????????????? - ??????????OTC???????????????
???????????????????????????????????????????“Medication Guide”??????? - ?????????????????
?????????????????????????????????????(???????)??????? - ???????????????
?????????????????????????????????????????????????
???????????OTC?????CHPA?Consumer Healthcare Products Association???????????????????????????????????????????????
Statement from the Consumer Healthcare Products Association (CHPA) on FDA’s Options Paper Regarding Acetaminophen?CHPA?2009.5.27????????
????????????????????????????OTC??????????????????????????????????????
?????TOPICS
??2009.04.29 OTC???????????????????????
??2005.12.04 ???????????????????
???
FDA group recommends acetaminophen liver warnings
?ABC NEWS 2009.5.27?AP???
?http://abcnews.go.com/Health/wireStory?id=7691765
Drugmakers May Limit Doses, Add Warnings for Tylenol
(Bloomberg 2009.5.27)
?http://www.bloomberg.com/apps/news?pid=20601103&sid=an0NgFGyErgU&refer=us
5?30??15:30??????6?3? 10:50??
FDA????(?)??????????????????
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FDA?????????????????????
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