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Results: 1-10 of 33

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


Supreme Court's Refusal to Hear POM Wonderful's Appeal Demonstrates Important Distinction Between Disease Claims and StructureFunction Claims
  • Sidley Austin LLP
  • USA
  • May 11 2016

The United States Supreme Court denied POM Wonderful's final bid to overturn a Federal Trade Commission (FTC) decision that the company deceptively


FDA changes course on INDs for food and supplement studies, but not for cosmetics
  • Sidley Austin LLP
  • USA
  • October 30 2015

FDA announced today that it is indefinitely staying portions of the Guidance, "Investigational New Drug Applications - Determining Whether Human


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


FDA draft guidance on Dear Health Care Provider letters carries potentially significant products liability implications
  • Sidley Austin LLP
  • USA
  • November 19 2010

The Food and Drug Administration (FDA) draft Guidance (Guidance) addressing the content and format of Dear Health Care Provider (DHCP) letterswhich are sometimes called "Dear Doctor" lettersis the first substantive guidance from FDA on this issue


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


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


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


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


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