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The New CBE Rule Is Final

By James M. Beck and Mark Herrmann

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.)

And here's a link to the final rule that went up at the FDA website today.

Full post as published by Drug and Device Law on August 22, 2008 (boomark / email).