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Results:1-10 of 34

China FDA Proposes Sweeping Rules to Regulate Medical Representatives
  • Sidley Austin LLP
  • China
  • December 28 2017

In January 2017, China's State Council announced that the medical representative (MR) profession would be subject to two new requirements. One


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On May 12, 2016, the Food and Drug Administration (FDA) finalized its August 2013 Draft Guidance, "Frequently Asked Questions About Medical Foods


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On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach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


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
  • USA, Global
  • 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


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


Increased FDA scrutiny of pre-approval communications continued in 2012
  • Sidley Austin LLP
  • USA
  • February 5 2013

Warning and untitled letters issued to prescription drug manufacturers in 2012 reflect continued FDA focus on pre-approval communications. FDA's