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Results: 1-10 of 82

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New FDA informed consent draft guidance broadens scope of sponsor disclosure obligations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On July 15, 2014, the U.S. Food and Drug Administration ("FDA" or the "Agency") issued a draft guidance document, entitled "Informed Consent

Decoding FDA: five things to know about the FDA’s June 6 response to the MIWG citizen petition concerning off-label promotion

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

On June 6, 2014, FDA sent a letter to counsel for the Medical Information Working Group (MIWG), a coalition of biopharmaceutical and medical

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

China amends its cornerstone Regulation on Medical Devices

  • Sidley Austin LLP
  • -
  • China
  • -
  • April 7 2014

On March 31, 2014, China's State Council published the amended Administrative Regulation on Medical Devices, which will become effective on June 1