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Results: 1-10 of 21

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 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New FDA draft guidance holds IVD manufacturers responsible for clinical use of ROUIUO products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FDA draft guidance on mobile apps signals increased regulatory oversight

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 27 2011

On July 20, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance identifying the mobile device applications“apps”the agency plans to regulate as medical devices

New draft guidance on companion diagnostics signals new responsibilities for pharma and dx companies and clinical laboratories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On July 14, U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance on In Vitro Companion Diagnostic Devices

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FDA issues draft guidance on medical device studies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 shift on diagnostics lays groundwork for regulation of lab-developed tests global life sciences - U.S. FDA update

  • Sidley Austin LLP
  • -
  • USA
  • -
  • July 15 2011

On July 12, 2011, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) announced plans to down-classify and exempt from Section 510(k) premarket notification a range of in vitro diagnostic and radiology device types

New House bill proposes FDA authority to require drug sponsors to develop companion diagnostics

  • Sidley Austin LLP
  • -
  • USA
  • -
  • June 11 2010

On May 27, 2010, Representatives Patrick Kennedy (D-RI) and Anna Eshoo (D-CA) introduced HR 5440, the Genomics and Personalized Medicine Act of 2010

FDA reopens comment period to address oversight of laboratory-developed tests

  • Sidley Austin LLP
  • -
  • USA
  • -
  • August 24 2010

Last week the U.S. Food and Drug Administration (FDA or the Agency) announced that it would reopen the comment period until September 15, 2010 to provide additional time for stakeholders to submit commentsand to update already submitted commentsregarding the Agency’s oversight of laboratory developed tests (LDTs) (75 FR 5120