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Results: 1-10 of 32

FDA's Final Medical Foods Guidance Maintains Restrictions on Category
  • Sidley Austin LLP
  • USA
  • May 16 2016

On May 12, 2016, the Food and Drug Administration (FDA) finalized its August 2013 Draft Guidance, "Frequently Asked Questions About Medical Foods


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


Shifting gears, FDA seeks input on use of the term “natural” in food labeling
  • Sidley Austin LLP
  • USA
  • November 12 2015

On Thursday, November 12, 2015, the Food and Drug Administration (FDA) announced that it was opening a docket to accept public comments on "natural"


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


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On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach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


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