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 28

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On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach


SFDA issues draft rules to define its discretionary power in imposing administrative penalties
  • Sidley Austin LLP
  • China
  • September 27 2012

On September 19, 2012, China’s State Food and Drug Administration (“SFDA”) issued draft Rules on Exercising Discretionary Powers when Imposing Administrative Penalties involving Drugs and Devices (“Draft Rules”), soliciting public comments by September 26, 2012


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


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


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


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


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