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New Final Rule Clarifies FDA's View On Preemption

Law360 (August 28, 2008, 12:00 AM EDT) -- On Aug. 22, 2008, the FDA published a final rule in the Federal Register entitled "Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices." The final rule modifies 21 CFR Parts 314, 601 and 814.

The FDA's stated objective in promulgating the final rule is to codify the FDA's "longstanding view concerning when a change to the labeling of an approved drug, biologic, or medical device may be made in advance of the agency's review and approval of such change..."

Specifically, the final...
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