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FDA rolls out new conflict rules

The Food and Drug Administration linkurl:unveiled;http://www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html new, tougher linkurl:conflict of interest;http://www.the-scientist.com/news/display/24056/ rules yesterday (Aug 4). Key among the regulations was one that linkurl:prohibits;http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACWaiverCriteriaFINALGuidance080408.pdf physicians or researchers who have more than $50,000 worth of financial interests in pharmaceutical or medical device companies from

Bob Grant
Bob Grant

Bob Grant is Editor in Chief of The Scientist, where he started in 2007 as a Staff Writer.

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The Food and Drug Administration linkurl:unveiled;http://www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html new, tougher linkurl:conflict of interest;http://www.the-scientist.com/news/display/24056/ rules yesterday (Aug 4). Key among the regulations was one that linkurl:prohibits;http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACWaiverCriteriaFINALGuidance080408.pdf physicians or researchers who have more than $50,000 worth of financial interests in pharmaceutical or medical device companies from offering expert advice as members of linkurl:FDA advisory panels.;http://www.the-scientist.com/blog/display/53953/ The new rules, issued in one draft guidance and four final guidance documents, also state that the FDA will linkurl:publically release;http://www.fda.gov/oc/advisory/GuidancePolicyRegs/AC48HourFINALGuidance080408.pdf briefing materials pertaining to advisory committee meetings no later than 48 hours before the meeting occurs, and that votes taken at these meetings will occur linkurl:simultaneously;http://www.fda.gov/oc/advisory/GuidancePolicyRegs/ACVotingFINALGuidance080408.pdf rather than sequentially, avoiding the potential for one vote to affect the next. The FDA also claims to have made its linkurl:Web site;http://www.fda.gov/ more navigable so that the public can easily access information relating to advisory panels. "It's imperative that we seek advice from independent experts, and that we do so in...

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