Monday, August 25, 2008
The FDA issued a new final rule [PDF] relating to "changes being effected" -- i.e., changes that a drug manufacturer can make to its label without advance permission. The focus of the changes is on emphasizing that it relates to new risk information, and that the CBE process isn't appropriate for tweaks to old risk information. It also reiterates the FDA's position that compliance with its regulations results in preemption of state tort claims.
The Drug & Device Law Blog has more, following up on their first look back in January. No surprise that they like the rule, but even if you disagree on the value of it, their analysis of its mechanics is worth reading.