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Pharmaceutical companies laud FDA’s breakthrough drug approval procedures
  • Shook Hardy & Bacon LLP
  • USA
  • September 12 2013

Since the Food and Drug Administration Safety and Innovation Act was enacted in July 2012, the Food and Drug Administration (FDA) has received 82


Drug maker brings first amendment challenge to off-label use rules
  • Shook Hardy & Bacon LLP
  • USA
  • November 3 2011

Par Pharmaceutical, Inc. has filed a declaratory judgment action against the U.S. Food and Drug Administration (FDA) in a District of Columbia federal court, seeking an order barring the agency from enforcing regulations that criminalize off-label drug promotions on the ground that they violate First Amendment free speech rights.