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Obama FDA’s Parting Shot On Off-Label Promotion And The First Amendment
  • Reed Smith LLP
  • USA
  • January 18 2017

We haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which

The 21st Century Cures Act
  • Arnold & Porter Kaye Scholer LLP
  • USA, United Kingdom
  • December 16 2016

Following a multi-year, bipartisan, and bicameral effort to accelerate the pace of the discovery, development, and delivery of new treatments...

Health Law Update - December 1, 2016
  • Baker & Hostetler LLP
  • USA
  • December 1 2016

Welcome to this week's edition of the Health Law Update. In this Issue...

New Changes to US-Cuba Regulations Further Clarify and Ease Restrictions
  • Hunton Andrews Kurth LLP
  • USA, Cuba
  • October 14 2016

In a continued effort to implement the policy change announced by President Obama on December 17, 2014, to engage and empower the Cuban people, the

Personalized Medicine: Insights Into Current Legal Issues
  • Foley & Lardner LLP
  • USA
  • September 18 2016

In his January 20, 2015 State of the Union Address, President Obama brought to the nation’s attention the promise of personalized medicine when he

Food, Dietary Supplement & Cosmetics Regulatory Update, Vol. III, Issue 11
  • Jones Day
  • USA, Brazil, European Union
  • August 12 2016

On July 29, 2016, President Obama signed into law S.764, the bill that creates the "National Bioengineered Food Disclosure Standard." As discussed in

President Obama Signs Federal GMO Law, Preempts Vermont Law
  • K&L Gates
  • USA
  • August 8 2016

On July 29, 2016, U.S. President Barack Obama signed into law the first U.S. federal law requiring food manufacturers and distributors to label

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine
  • Foley & Lardner LLP
  • USA
  • August 4 2016

Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development

Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 6
  • Jones Day
  • USA, United Kingdom, European Union
  • August 3 2016

FDA recently released, as a part of President Obama's Precision Medicine Initiative, two draft guidance documents proposing what the Agency is

President Obama Signs S. 764 into Law, Preempting the Vermont GE Labeling Law
  • Keller and Heckman LLP
  • USA
  • August 1 2016

We have previously discussed the provisions of the National Bioengineered Food Disclosure Standard (S. 764) in a client alert titled "United States