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2009年5月28日(木)

????????????????????????????

投稿者: ????????

?????????????????????????????????????????????6?29??30??????????4?29??TOPICS??????????????????????FDA??????working group????????????????????????????????????????????????????????????MEMORANDUM??????????27????????

Food and Drug Administration Drug Safety and Risk Management Advisory Committee, Anesthetic and Life Support Drugs Advisory Committee and Nonprescription Drugs Advisory Committee June 29-30, 2009

?MEMORANDUM?FDA Briefing Material??PDF:6.84MB??BRIEFING INFORMATION?

?????????????????????OTC????????????????????????????????

  1. ????????????????????????????????????
  2. ???????????????????????
    ?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????3??????????????????????????????????????????????????????????????
  3. ?????????3250mg????4000mg??????????????3???????????????????
  4. 1?????????325mg?????????????????650mg????1000mg?????
  5. ??????????
    ?160mg/5ml??????????????????????2???????
  6. ?????????
  7. ????????????????????????

??????????????????????

  1. ????????????OTC????
  2. ?????????
    ????????????OTC???????????????????????????????????Medication Guide??????
  3. ??????????????
  4. OTC?????????????????

?????????????????????????????????????????????????

  1. 500????????????????????
  2. OTC???????????????????????
    ?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????NSAIDS??????????????
  3. ???????????
  4. ??????????????
  5. ??????????APAP???????????????????????

??????????????????????????????????????????????????????????????????????????????????????????????????

Options Paper and Memorandum(??????????????)
?http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4429b1-01-FDA.pdf  

  1. ??????1?325mg?1???650mg??????????????????????
  2. ??????????????
  3. ????????????????1?????????????
    ??????????????????
  4. ??????????OTC???????????????
    ???????????????????????????????????????????�Medication Guide�???????
  5. ?????????????????
    ?????????????????????????????????????(???????)???????
  6. ???????????????
    ?????????????????????????????????????????????????

???????????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??

| 2009年05月28日 16:38 掲載 |
（category : Pharmacist, ???, ??????, ?????, ???????, ???, ??????）

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コメント (1)

  1. FDA????(?)??????????????????

    ????????????????????????FDA??????????????????

    FDA?????????????????????

    投稿者 by ???????? — 2009年6月3日(水)11:13

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