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Results: 11-20 of 76

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


Gottlieb confirmed as FDA commissioner; signals need to address regulation of generics, biosimilars
  • Loeb & Loeb LLP
  • USA
  • May 30 2017

In a split vote, the Senate confirmed the nomination of Scott Gottlieb as the next head of the FDA. Gottlieb emphasized the need to take action to


Vertical Pharmaceuticals hit with warning letter over deficient PADE reporting
  • Loeb & Loeb LLP
  • USA
  • May 30 2017

The letter takes issues with Vertical's protocols to monitor, receive, evaluate and report postmarketing adverse drug events and raises concerns about


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


President Trump signs ‘two out, one in’ executive order with implications for FDA
  • Loeb & Loeb LLP
  • USA
  • February 27 2017

The Executive Order requires at least two regulations be slashed to offset the costs associated with new regulations. For the current fiscal year


FDA’s enforcement stats paint opposing pictures for pharmaceuticals, medical devices
  • Loeb & Loeb LLP
  • USA
  • February 27 2017

The agency's annual enforcement report signals mixed enforcement trends for pharmaceutical companies and medical device makers. While the


FDA issues warning letter to Fresenius subsidiary over misleading promotional material
  • Loeb & Loeb LLP
  • USA
  • February 27 2017

For the second time, the FDA warned Fenwal about misleading promotional material for InterSol that omits risk information. The agency raises concerns


FDA Regulatory and Compliance Monthly Recap January 2017
  • Loeb & Loeb LLP
  • USA
  • January 27 2017

The draft guidance offers recommendations on how to ensure information presented in communications that are consistent with, but not included in


FDA publishes guidance outlining device reporting requirements for manufacturers under MDR regulation
  • Loeb & Loeb LLP
  • USA
  • November 29 2016

The guidance outlines the FDA's interpretation of regulatory requirements under MDR regulation and provides input on what types of reports


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