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Results: 1-10 of 30

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


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 addresses oversight of general wellness products, device accessories
  • Sidley Austin LLP
  • USA
  • January 22 2015

On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach


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


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 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


Major vaccine standards change in China
  • Sidley Austin LLP
  • China
  • January 24 2011

The State Food and Drug Administration ("SFDA") recently issued the Notice for Further Strengthening the Supervision of Quality and Safety of Vaccines ("Vaccine Notice"


Recent SFDA and MOH new developments
  • Sidley Austin LLP
  • USA
  • January 21 2011

The State Food and Drug Administration ("SFDA, the Agency") issued an order in late December 2010 to require compulsory incorporation of a monitoring bar code issued by the agency in the direct packaging materials of compound pharmaceutical formulations containing ephedrine, codeine and diphenoxylate, in order to prevent abuse and misuse of such products


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