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Results: 1-10 of 30

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


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


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


FDA announces two pilot projects for improving ways to trace sources of foodborne illness; FDA will solicit stakeholder input in designing and implementing the pilots
  • Sidley Austin LLP
  • USA
  • September 15 2011

On September 7, 2011, the U.S. Food and Drug Administration (FDA) announced that it is moving forward with two pilot projectsone for processed foods and the other for producedesigned to help the agency and the food industry, including farms, restaurants, and grocery stores, more rapidly and effectively trace products back to a contamination source during outbreaks of foodborne illness


FDA issues draft guidance on medical device studies
  • Sidley Austin LLP
  • USA
  • November 18 2011

On November 10, 2011, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents with the stated purpose of encouraging medical device research and innovation of significant risk medical devices


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


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


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 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 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