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Results: 11-20 of 49

FDA final guidance on research use onlyinvestigational use only diagnostics shifts focus to manufacturer promotion
  • Sidley Austin LLP
  • USA
  • December 5 2013

On November 25, 2013, the Food and Drug Administration (FDA) finalized its June 1, 2011 draft guidance on RUOIUO IVDs, omitting the most


FDA says it will not actively regulate low-risk mobile medical apps
  • Sidley Austin LLP
  • USA
  • October 1 2013

On September 23, 2013, FDA issued final guidance on its approach to regulating "mobile medical apps" for smart phones, tablets, and other mobile


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


FDA issues draft guidance on medical device reporting (mdr) and answers industry questions on specific issues
  • Sidley Austin LLP
  • USA
  • July 10 2013

On July 8, 2013, the Food and Drug Administration (FDA) announced the availability of a draft guidance, "Medical Device Reporting for Manufacturers,"


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


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FDA releases draft guidance concerning clinical trials
  • Sidley Austin LLP
  • USA
  • December 6 2012

On November 20, the Food and Drug Administration (FDA) took another step toward modernizing clinical trial oversight by issuing two draft guidance documents related to the conduct of clinical trials


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


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