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Results: 1-10 of 85

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On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach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

8th Circuit affirms dismissal of FCA claim, offering guidance on the application of the public disclosure bar

  • Sidley Austin LLP
  • -
  • USA
  • -
  • August 18 2014

On August 7, 2014, the Eighth Circuit affirmed the dismissal of a qui tam False Claims Act suit, and in doing so offered helpful guidance regarding

New FDA informed consent draft guidance broadens scope of sponsor disclosure obligations

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 22 2014

On July 15, 2014, the U.S. Food and Drug Administration ("FDA" or the "Agency") issued a draft guidance document, entitled "Informed Consent