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.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 33

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


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


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


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


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


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