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Par files complaint against the Government claiming that FDA's off-label marketing regulations violate the First Amendment

  • Kelley Drye & Warren LLP
  • -
  • USA
  • -
  • October 27 2011

Par filed a Complaint for Declaratory and Injunctive Relief against the United States, the U.S. Food & Drug Administration (FDA), the Commissioner of the FDA, and the Secretary of the Department of Health & Human Services seeking a declaratory judgment that the application of FDA off-label marketing regulations to Par’s marketing of Magace ES violates the First Amendment