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FDA Overhauls Design and Content of Nutrition Labeling
  • Sidley Austin LLP
  • USA
  • May 26 2016

On May 20, 2016, the Food and Drug Administration (FDA) announced the release of two final rules amending its nutrition labeling regulations. The


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On May 12, 2016, the Food and Drug Administration (FDA) finalized its August 2013 Draft Guidance, "Frequently Asked Questions About Medical Foods


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On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach


Clinical trial transparency remains a global issue as NIH issues a notice of proposed rulemaking on clinical trials registration and results submission
  • Sidley Austin LLP
  • Global, USA
  • December 1 2014

On November 21, 2014, the National Institutes of Health (NIH) published a notice of proposed rulemaking that would expand the clinicaltrials.gov


Top 10 steps global life sciences companies should take in 2014
  • Sidley Austin LLP
  • USA
  • February 24 2014

Prepare now for difficult-to-defend challenges to biological patents. Most innovative biological product companies have little experience with the


China develops new rules to simplify medical device re-registration process
  • Sidley Austin LLP
  • China
  • April 1 2013

China's newly restructured food and drug regulatory agency, the China Food and Drug Administration ("CFDA"), has published new draft rules to


SFDA 2012 Anual Drug Review Report highlights innovator focus
  • Sidley Austin LLP
  • China
  • March 8 2013

On February 28, 2013, the Center for Drug Evaluation of the State Foodand Drug Administration ("CDE"), the key agency reviewing safety andefficacy


Top 10 steps global life sciences companies should take in 2013
  • Sidley Austin LLP
  • USA
  • March 1 2013

Engage in US budget and deficit reduction process. As governments, including the US and China, search for the means to fund priorities or reduce


FDA finalizes guidance to address potential bias and conflicts of interest in clinical investigations
  • Sidley Austin LLP
  • USA
  • March 1 2013

FDA has finalized its guidance on financial disclosure for clinical investigators. A draft of the guidance, published in May 2011, was developed in