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Industry stakeholders offer input on FDA’s draft guidances on off-label communications
  • Loeb & Loeb LLP
  • USA
  • May 30 2017

Industry stakeholders are weighing in on the two draft guidances issued by the FDA outlining how drug and device companies can discuss off-label uses

Industry groups say final rule on intended use establishes unfounded legal standard, call for indefinite stay
  • Loeb & Loeb LLP
  • USA
  • February 27 2017

Citing violations of the APA and what they call the establishment of a "new and unjustified legal standard," a coalition of industry groups is

FDA finalizes rule on citizen petitions delaying generic approvals; declines PhRMA requests
  • Loeb & Loeb LLP
  • USA
  • November 29 2016

He final rule makes clear that the FDA will not delay the approval of pending ANDA, 505(b)(2) or 351(k) applications because of citizen petitions