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Results: 1-10 of 25

FDA to finalize GRAS notification rule; potential for more stringent standards

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

On October 20, 2014, the Food and Drug Administration (FDA) entered into a consent decree under which the Agency is obligated to finalize its 1997

FDA guidances pose regulatory challenges for functional foods

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 29 2014

The Food and Drug Administration recently finalized two guidance documents for dietary supplement manufacturers, one focused on Distinguishing Liquid

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

FDA proposes two groundbreaking food safety rules

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 8 2013

On January 4, 2013, the U.S. Food and Drug Administration ("FDA" or the "Agency") proposed two major, long-awaited rulemakings required by the Food Safety

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

SFDA issues draft rules to define its discretionary power in imposing administrative penalties

  • Sidley Austin LLP
  • -
  • China
  • -
  • September 27 2012

On September 19, 2012, China’s State Food and Drug Administration (“SFDA”) issued draft Rules on Exercising Discretionary Powers when Imposing Administrative Penalties involving Drugs and Devices (“Draft Rules”), soliciting public comments by September 26, 2012

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