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Results:1-10 of 71

FDA’s CDER, CDRH and CBER publish 2015 guidance agendas
  • Loeb & Loeb LLP
  • USA
  • February 13 2015

The FDA's Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and Center for Biologics Evaluation and


FDA regulatory and compliance monthly recap September 2015
  • Loeb & Loeb LLP
  • USA
  • September 30 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel FDA draft


FDA Regulatory and Compliance Monthly Recap July 2018
  • Loeb & Loeb LLP
  • USA
  • July 9 2018

The Office of Prescription Drug Promotion (OPDP) issued separate untitled letters to Pfizer and Arog raising concerns about promotional materials. The


FDA Regulatory and Compliance Monthly Recap - September 2016
  • Loeb & Loeb LLP
  • USA
  • September 30 2016

FDA issues final rule modifying regulations for drug establishment


Draft documents on drug compounding and repackaging issued by the FDA help entities comply with public health provisions
  • Loeb & Loeb LLP
  • USA
  • March 5 2015

The regulator published five draft documents as part of a larger series of policy documents concerning the FDA's oversight of drugs produced by


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


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


FDA regulatory and compliance monthly recap December 2015
  • Loeb & Loeb LLP
  • USA
  • January 6 2016

The pharmaceutical industry won in its latest bid for more leeway to promote drugs for unapproved uses, as the Food and Drug Administration agreed to


FDA provides guidance on orphan drug meetings with OOPD
  • Loeb & Loeb LLP
  • USA
  • August 7 2015

The regulator issued recommendations for stakeholders seeking meetings with the OOPD, in a bid to provide consistent procedures that promote


FDA provides guidance on assessing potential risks to embryofetal development posed by drugs used by men
  • Loeb & Loeb LLP
  • USA
  • July 8 2015

The regulator's guidance document contains recommendations for evaluating what the potential is for API exposure in males to adversely affect