?????R?????????

?TOPICS 2009.05.28 ??????????FDA?6?29??30??2???????35???????????????????????????????????????????????????????PDF??

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

?30????FDA???????????Options Paper and Memo?PDF?21????????9????????????????????????????????????????????????????????????

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

Questions and Vote Results for the June 29-30, 2009 Joint Meeting of the Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee (PDF - 747KB)?FDA?Committees & Meeting Materials?

???????????????????????????Urtracet??????????????Vicodin??????????????????????????????????????????????????????2?????????????????????????????????????????????????????????????????????????Vicodin??????????????????????????????????

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

???ABC??????????????????OTC???????“unit-of-use”????????????????????????????????????????????325???????????1000?????????????????????????????1000?1??25?????????????????

??????????????????????????????Briefing Information ???????????????????

• ?????Options Paper and Memo??PDF?21???
• FDA???????????????Working Group Report??PDF?249???
• ????????????????study?????????????Addendum??PDF?15???
• 40???????????????????????? Rocky Mountain Poison and Drug Center ??????????PDF?13????
• ?????CHPA:Consumer Healthcare Products Association?????????????????PDF?46????
• tramadol ?????????????????ULTRACET??????Johnson & Johnson???????PDF?29????
• Tylenol ?????????McNeil Consumer Health Care???????PDF?249????

????????????????CHPA?????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????

Statement from the Consumer Healthcare Products Association on Today’s Joint FDA Advisory Committee Recommendations on Over-the-Counter Medicines Containing Acetaminophen
?CHPA 2009.6.30?
?http://www.chpa-info.org/06_30_09_acetaminophen.aspx

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

??????????????????????????????????????????????????????FDA?OTC???????????????????????????

?????TOPICS
?2009.05.28?????????????????????????????
?2009.04.29?OTC???????????????????????
?2005.12.04????????????????????

???
FDA Panel Urges Cuts in Acetaminophen Dosage
?ABC NEWS 2009.630?
?http://abcnews.go.com/Health/PainManagement/story?id=7965902
FDA Panel Backs ‘Black Box’ Warning for Acetaminophen Prescription Combos
?Medpage TODAY 2009.6.30?
?http://www.medpagetoday.com/Washington-Watch/Washington-Watch/14922
FDA Panel Urges Ban on Vicodin, Percocet
?Health Day 2009.6.30?
?http://www.healthday.com/Article.asp?AID=628586
Panel Recommends Ban on 2 Popular Painkillers
?New York Times 2009.6.30?
?http://www.nytimes.com/2009/07/01/health/01fda.html?hp
Experts urge stronger limits for some pain drugs
?Reuter?2009.6.30?
?http://www.reuters.com/article/domesticNews/idUSTRE55S62120090630

7?1??19:30?3??16:20??