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January 19, 2006
FDA Rulemaking
The Products Liability Prof blog has noted the new FDA rulemaking reiterating/declaring the agency's current view that state law labeling claims are generally preempted. A couple of document pointers may be helpful:
The relevant part of the rule starts on page 38 of this document [PDF].
Or, if you'd rather just see the most relevant 9 pages instead of all 100, I've excerpted them in this document [also PDF, but only 1.9 MB instead of 9.7].
ATLA's press release on the topic is available here.
[Disclosure: In practice I did pharmaceutical tort defense and continue as a consultant in ongoing litigation.]
January 19, 2006 | Permalink
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Comments
What, if any, retroactive effect will the preemptive provisions of the new FDA rule have?
Posted by: DW | Jan 19, 2006 8:46:28 AM
ATLA link is munged.
Posted by: Ted | Jan 19, 2006 5:03:29 PM
Ted: Thanks for the catch; fixed it.
DW: Interesting question. I'll do a post with my initial thoughts about it.
Posted by: Bill Childs | Jan 21, 2006 9:40:25 AM
