October 4, 2007
Bush signs FDA Amendments Act of 2007
President Bush signed the FDA Amendments Act of 2007 (H.R. 3580) last week. From CCH Health Care:
The law will: (1) reauthorize user fees for FDA approvals of drugs and devices and authorize new fees for FDA approvals of TV drug ads; (2) require some drug sponsors to conduct post-approval studies and/or clinical trials of high-risk drugs; (3) encourage development of products for children by permitting the FDA to ask for pediatric research on drugs and devices and pediatric labeling on drugs; (4) limit conflicts of interest by forbidding participation in advisory committee meetings by those with financial interests; (5) require the FDA to work with the National Institutes of Health to set up clinical trial databases that will include adverse event information and that can be searched by the public; and (6) require the FDA to establish pet food standards and to establish a registry to track all adulterated food.
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