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Results: 1-10 of 947

Life Sciences: Compliance and enforcement in the USA
  • Perkins Coie LLP
  • USA
  • October 11 2017

A structured guide to compliance and dishonest practices in the USA


The Past, Present, and Future of Government Regulation of Off-Label Communications - Part 4
  • Mintz Levin
  • USA
  • August 14 2017

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent


Fifth Circuit Affirms Defense Verdict and Dismissals of Off-Label FCA Claims
  • Sidley Austin LLP
  • USA
  • June 13 2017

Last week, the Fifth Circuit affirmed a defense verdict and the earlier dismissal of several False Claims Act claims related to the alleged off-label


Capitol Hill Healthcare Update
  • Baker & Hostetler LLP
  • USA
  • June 12 2017

Senate Republicans continue intra-party discussions on changes to House-passed legislation replacing the Affordable Care Act (ACA


President Trump’s Proposed FY 2018 Budget Spares Medicare, But Calls for Deep Medicaid Cuts & FDA User Fee Hikes
  • Reed Smith LLP
  • USA
  • June 1 2017

President Trump has released his FY 2018 budget proposal, which the Administration dubs "A New Foundation for American Greatness." The proposed


New FDA Commissioner Hits the Ground Running
  • Foley & Lardner LLP
  • USA
  • May 30 2017

Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and


Let Food Be Thy Medicine, But Mind Your Words
  • Davis Wright Tremaine LLP
  • USA
  • May 24 2017

A tweet last week from Project Nosh set my food-labeling-lawyer-head buzzing: “Consumers are looking for snacks that aren’t just empty calories


Senate Confirms Dr. Gottlieb's Nomination as FDA Commissioner
  • Jones Day
  • USA
  • May 12 2017

On May 9, 2017, the Senate confirmed Dr. Scott Gottlieb as the next FDA commissioner. With a 57-42 vote, the Senate fills the commissioner position


Capitol Hill Healthcare Update
  • Baker & Hostetler LLP
  • USA
  • April 25 2017

Although House Republicans made progress on bridging ideological differences over how to replace the Affordable Care Act (ACA), GOP leaders say not to


Pharmaceutical & Medical Device Regulatory Update, Vol. IV, Issue 1
  • Jones Day
  • USA
  • April 12 2017

One day before the final rule, "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products