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Home » The New CBE Rule Is Final

The New CBE Rule Is Final

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By Bexis on August 22, 2008
Posted in FDA, Preemption

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.)

 

Tags: CBE Regulation
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