Between You And Me: FDA Comments Not Disclosure Events
April 23, 2012, 1:14 PM EDT
Law360, New York (April 23, 2012, 1:14 PM EDT) -- In an important ruling dismissing a comprehensive securities class action complaint against Genzyme Corp., the U.S. District Court for the District of Massachusetts held last week that regulatory comments and inspectional observations provided by the U.S. Food and Drug Administration (FDA) to pharmaceutical companies like Genzyme — including commentary supplied on FDA Form 483 — are of “questionable materiality” and are not automatically required to be disclosed by regulated issuers.
The decision means that the plaintiffs’ bar will not be able to leverage critical comments delivered...
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