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Results: 1-10 of 18

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

House drug safety hearing highlights FDA focus on product safety and supply chain obligation

  • Sidley Austin LLP
  • -
  • USA
  • -
  • March 12 2010

On March 10, 2010, Dr Joshua M Sharfstein, Principal Deputy Commissioner of the Food and Drug Administration (FDA), presented testimony at the House of Representatives' Committee on Energy and Commerce, Subcommittee on Health hearing on drug safety

Second Circuit rejects FDA regulation of “off-label” promotion as misbranding in Caronia case

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 3 2012

In a widely anticipated ruling, the United States Court of Appeals for the Second Circuit this morning reversed the conviction of pharmaceutical sales representative Alfred Caronia for misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA), based on alleged “off-label” promotion

GAO report on food labeling might signal renewed FDA resistance to qualified health claimsglobal life sciences: US-FDA update

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 24 2011

On January 14, 2011, the U.S. Government Accountability Office (GAO) issued a report entitled, “Food Labeling: FDA Needs to Reassess its Approach to Protecting Consumers from False or Misleading Claims,” regarding the use of qualified health claims and structurefunction claims for food products

Senate passes food safety legislation: food product and dietary supplement implications

  • Sidley Austin LLP
  • -
  • USA
  • -
  • December 7 2010

On November 30, 2010, the Senate approved the long-awaited Food Safety Modernization Act, S. 510, by a 73-25 vote

New draft guidance on companion diagnostics signals new responsibilities for pharma and dx companies and clinical laboratories

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 26 2011

On July 14, U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance on In Vitro Companion Diagnostic Devices

New FDA draft guidance holds IVD manufacturers responsible for clinical use of ROUIUO products

  • Sidley Austin LLP
  • -
  • USA
  • -
  • June 16 2011

In a new proposed guidance, FDA has signaled its intention to shift responsibility for the use of certain medical devices from customers to manufacturers, based on an expansive and legally questionable presumption of “intent.”

FDA request for comments on timing for implementation of safety labeling changes

  • Sidley Austin LLP
  • -
  • USA
  • -
  • January 4 2012

On December 20, 2011, the U.S. Food and Drug Administration (FDA) published a notice requesting public input on the deadlines for implementing drug safety labeling changes

FDA proposes two safety rules governing imported foods

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 31 2013

On July 29, 2013, the U.S. Food and Drug Administration ("FDA" or the "Agency") published two significant, long-awaited proposed rules mandated by

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