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Results: 1-10 of 156

Court dismisses GMP-based FCA claims with prejudice
  • Sidley Austin LLP
  • USA
  • June 16 2015

On Friday, the Northern District of California dismissed with prejudice claims alleging that a failure to obtain supplemental approval for major


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


Court rejects off-label promotion allegations due to failure to cite actual false claim submissions; allows retaliation claims to proceed
  • Sidley Austin LLP
  • USA
  • April 2 2015

On March 27, 2015, a federal court in the Southern District of Ohio granted in part and denied in part a motion to dismiss a qui tam suit alleging


A year of global change 2015: what multinational life sciences companies should expect in China
  • Sidley Austin LLP
  • China
  • March 4 2015

With China marching into the Year of the Ram, multinational life sciences companies should anticipate and be prepared for regulatory changes and


FDA addresses oversight of general wellness products, device accessories
  • Sidley Austin LLP
  • USA
  • January 22 2015

On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach


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


Italian Competition Authority imposes significant fine for misleading health claim
  • Sidley Austin LLP
  • Italy
  • December 1 2014

The Italian Competition Authority (Autorità Garante della Concorrenza e del Mercato, the AGCM) recently imposed a fine of 250,000 on a manufacturer


New medical device regulations in Japan
  • Sidley Austin LLP
  • Japan
  • October 23 2014

Major amendments to Japan's Pharmaceutical Affairs Act of 1960 (the "Act") will come into effect on November 25, 2014. One of the purposes of these


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


FDA moves forward with program for Medical Device Development Tools
  • Sidley Austin LLP
  • USA
  • September 8 2014

On August 15, 2014, FDA announced that it is soliciting proposals to participate in a pilot program for Medical Device Development Tools (MDDTs