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Results: 1-10 of 19

China encourages pharmaceutical companies to timely pursue new GMP certification

  • Sidley Austin LLP
  • -
  • China
  • -
  • January 15 2013

In 2010, China's State Food and Drug Administration ("SFDA") issued a new version of its Good Manufacturing Practice (the "GMP") regulations, which

EU court rules on classification of certain borderline products as medical devices

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • December 3 2012

In a judgment published on November 22, 2012, the Court of Justice of the European Union (CJEU) confirmed that products intended for the investigation of physiological processes only fall within the scope of the EU Medical Device Directive (9342EEC), as implemented into EU Member State legislation, if the products are intended for a medical purpose

Significant overhaul of EU medical devices regime planned

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • October 29 2012

On 26 September 2012, the European Commission published the proposals for two new Regulations intended to replace the EU directives that govern medical devices intended to be placed on the EU market

FDA issues warning letter to Lancôme for anti-aging claims

  • Sidley Austin LLP
  • -
  • USA
  • -
  • September 14 2012

On September 7, 2012, the compliance office within the Center for Food Safety and Applied Nutrition (CFSAN) at FDA issued a Warning Letter to Lancôme USA, a subsidiary of L’Oréal, regarding several anti-aging skin care products being marketed as cosmetics

New Chinese medical device GCP unveiled for public comments

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 4 2012

The Chinese State Food and Drug Administration (“SFDA”) published the revised Medical Device Good Clinical Practice (“Medical Device GCP”) in late August and is soliciting public comments until September 30, 2012

SFDA to enforce blacklist system for unsafe drug and device products

  • Sidley Austin LLP
  • -
  • China
  • -
  • August 21 2012

Beginning October 1, 2012, China’s State Food and Drug Administration (SFDA), including its provincial counterparts, will implement a nationwide information disclosure system called the Drug Safety Blacklist (“Blacklist”), which includes medical device products as well

Appeals Court issues important ruling in fraud and abuse case involving individual liability

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 31 2012

A recent D.C. Circuit decision in Friedman v. Sebelius overturned the exclusions of three Purdue pharma executives from participation in federal healthcare programs, holding that the Department of Health and Human Services acted arbitrarily in imposing extraordinarily lengthy exclusions

Extended scope EU Penalties Regulation enters into force

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • July 13 2012

As of 2 July 2012, infringements of the EU’s paediatric and new pharmacovigilance rules fall within the scope of the revised EU Penalties Regulation and are now subject to financial penalties of up to 5 percent of the marketing authorization holder’s annual EU turnover

European Parliament calls for additional medical device safety measures

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • June 18 2012

On 14 June 2012, the European Parliament (“EP”) adopted a Resolution calling on EU Member States and the European Commission to introduce and implement new measures aimed at ensuring the safety of medical devices

CMS seeks comments on its long-awaited Sunshine Act proposed rule

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 21 2011

The Centers for Medicare & Medicaid Services recently published a proposed rule implementing the Physician Payment Sunshine Act (section 6002 of the Affordable Care Act