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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

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

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

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

China's new SFDA priorities

  • Sidley Austin LLP
  • -
  • China
  • -
  • February 1 2011

The General Commissioner of the State Food and Drug Administration ("SFDA") unveiled six key priorities of the agency in 2011 at the General Assembly of Food and Drug Administrations in China

China SFDA publishes new technical review guidelines for drugs

  • Sidley Austin LLP
  • -
  • China
  • -
  • March 29 2011

On March 23, 2011, the Center for Drug Evaluation (CDE) of the PRC State Food and Drug Administration (SFDA), the equivalent of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration, published new guidelines for its technical review of drug registration applications in China (the Guidelines), including applications for clinical studies (IND), applications for production and market approvals of new drugs (NDA), as well as applications for generic drugs (ANDA

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

New age of Singapore’s regulations of medical devices

  • Sidley Austin LLP
  • -
  • Singapore
  • -
  • June 9 2011

In the past several years, Singapore has been in the process of revamping its regulatory regime for health products

European Union adopts falsified medicines directive

  • Sidley Austin LLP
  • -
  • European Union
  • -
  • June 7 2011

On May 27, 2011 the Council of the European Union (Council) adopted a directive aimed at preventing falsified medicines from entering into the legal supply chain

Senate passes food safety legislation: food product and dietary supplement implications

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 7 2010

On November 30, 2010, the Senate approved the long-awaited Food Safety Modernization Act, S. 510, by a 73-25 vote