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FDA's new "Changes Being Effected" regulation



Beck and Herrmann give a lengthy, but must-read, explanation why the esoteric 21 C.F.R. � 314.70(c)(6)(iii) is of critical importance in the ongoing question of whether state courts can penalize pharmaceutical companies for failing to contravene federal regulations—i.e., the question of preemption.

Speaking of preemption, January 18 is the day when the Supreme Court decides whether to grant cert in the important case of Wyeth v. Levine (May 22). As per usual, Beck and Herrmann have that well covered, too, with a post on the solicitor general's brief.

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Isaac Gorodetski
Project Manager,
Center for Legal Policy at the
Manhattan Institute
igorodetski@manhattan-institute.org

Katherine Lazarski
Press Officer,
Manhattan Institute
klazarski@manhattan-institute.org

 

Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.