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: Drug and Device Law

What's the FDA's View of Preemption in the Generic Drug Context?

By James M. Beck and Mark Herrmann

We don't know, but we're likely to find out soon.  In the consolidated appeal of the Smith v. Wyeth, Wilson v. Pliva, and Morris v. Wyeth cases (see our drug preemption scorecard for details), the Sixth Circuit has formally requested the FDA's views on this subject, and has given the FDA until July 29, 2010 to file it's brief.  We'll check back then to see what, if anything, the Agency has to say.

A tip of the hat to ... you know who you are.

Full post as published by Drug and Device Law on July 05, 2010 (boomark / email).

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