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Drug & Device Law

The definitive source for intelligent commentary on the law that matters for drug and device product liability cases

The New CBE Rule Is Final

By Bexis on August 22, 2008
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The FDA has finalized the new CBE rule. (That’s the so-called “Change Being Effected” rule at 21 C.F.R. Sec. 314.70(c)(6) for drugs.)
Here was our post on that subject when the FDA proposed the rule in January. (We explain there why this change is a big deal.)
 

Posted in FDA, Preemption
Tags: CBE Regulation

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