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New genetically engineered foods disclosure law enacted
  • Sidley Austin LLP
  • European Union, USA
  • August 10 2016

On July 29 2016 President Obama signed into law S764, which mandates the establishment of federal disclosure standards applicable to "bioengineered"


EU Institutions Agree on Overhaul of Medical Device and IVD Rules
  • Sidley Austin LLP
  • European Union
  • June 23 2016

On June 15, 2016, the European Council's Permanent Representatives Committee and the European Parliament's Environmental Committee, supported by the


Sidley Global Pricing newsletter - V4 2016
  • Sidley Austin LLP
  • United Kingdom, USA, France, Germany, India, Netherlands, Spain, Sweden, Australia, Belgium, Canada, China, European Union
  • January 27 2016

The Australian Pharmaceutical Benefits Pricing Authority (PBPA) ceased operations on April 1, 2014, in a move by the government to improve drug


New EU Guideline facilitates global development of biosimilars
  • Sidley Austin LLP
  • European Union
  • May 4 2015

On April 30, 2015, a new EU Guideline on biosimilar medicines took effect. The new Guideline defines a number of concepts applied by the EMA in its


EU publishes new GMP Regulation and guidelines
  • Sidley Austin LLP
  • European Union
  • December 11 2014

The European Commission's long-awaited Delegated Regulation on Good Manufacturing Practice (GMP) principles and guidelines for active substances for


EU Commission shifts responsibility for pharmaceuticals, medical devices, biotechnology and cosmetics
  • Sidley Austin LLP
  • European Union
  • September 18 2014

On September 10, 2014, European Commission President-elect Juncker issued a press release unveiling his new EU executive team and announcing a


Sidley Austin LLP global pricing newsletter - volume three 2014
  • Sidley Austin LLP
  • Brazil, Canada, China, European Union, France, Germany, India, United Kingdom, USA
  • April 15 2014

On October 21, 2013, Brazil’s National Agency of Supplemental Health enacted Normative Resolution 388, which mandated that all private healthcare


Overhaul of EU medical device and diagnostic legislation faces further delays
  • Sidley Austin LLP
  • European Union
  • December 13 2013

The latest December 10, 2013 discussions between EU Member States on new EU medical device and in vitro diagnostic (IVD) regulations reveal continued


Update on overhaul of EU medical device regime
  • Sidley Austin LLP
  • European Union
  • June 20 2013

An important step in the European Union's review of the two proposed regulations intended to replace the current three directives that form the EU


EU continues revision and implementation of strict GMP rules
  • Sidley Austin LLP
  • European Union
  • February 4 2013

In January 2013, three important developments regarding the EU's good manufacturing practice ("GMP") rules for medicinal products were made public: