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Results: 1-10 of 33

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On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach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


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


Major vaccine standards change in China
  • Sidley Austin LLP
  • China
  • January 24 2011

The State Food and Drug Administration ("SFDA") recently issued the Notice for Further Strengthening the Supervision of Quality and Safety of Vaccines ("Vaccine Notice"


Recent SFDA and MOH new developments
  • Sidley Austin LLP
  • USA
  • January 21 2011

The State Food and Drug Administration ("SFDA, the Agency") issued an order in late December 2010 to require compulsory incorporation of a monitoring bar code issued by the agency in the direct packaging materials of compound pharmaceutical formulations containing ephedrine, codeine and diphenoxylate, in order to prevent abuse and misuse of such products


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


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


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


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