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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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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.