We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
In cooperation with Association of Corporate Counsel
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 1-10 of 74

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

China issues implementation rules for its new pharmaceutical and medical device blacklist system

  • Sidley Austin LLP
  • -
  • China
  • -
  • March 19 2014

On December 27, 2013, China's National Health and Family Planning Commission (NHFPC) published an agency rule to update the "blacklist system" for

4th Circuit affirms dismissal of FCA suit premised on alleged violations of FDA GMP regulations

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 26 2014

On February 21, 2014, the Fourth Circuit upheld the dismissal of a former employee's False Claims Act suit against Omnicare, Inc. ("Omnicare"

China formulates special regulatory pathway for innovative medical device products

  • Sidley Austin LLP
  • -
  • China
  • -
  • February 11 2014

China Formulates Special Regulatory Pathway for Innovative Medical Device Products On February 7, 2014, the China Food and Drug Administration (CFDA

Supreme Court of Louisiana overturns $330 million judgment in off-label marketing case

  • Sidley Austin LLP
  • -
  • USA
  • -
  • February 4 2014

Last week, the Supreme Court of Louisiana reversed a $330 million judgment ($258 million in penalties, $70 million in attorney fees, and $3 million

China promulgates draft Good Supply Practices for Medical Devices

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 20 2014

The China Food and Drug Administration ("CFDA") published a draft of its first nationwide Good Supply Practice for Medical Devices (the draft "GSP"

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

District court dismisses conclusory allegations in off-label marketing suit

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 10 2013

In United States ex rel. Worsfold v. Pfizer Inc., No. 09-11522-NMG (D. Mass. Nov. 22, 2013), a federal district court in Massachusetts recently

President signs the Drug Quality and Security Act into law

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 2 2013

On November 27, 2013, the President signed the Drug Quality and Security Act (H.R. 3204) into law. This legislation is designed to clarify the Food