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Results: 1-10 of 30

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


Decoding FDA: five things to know about the FDA’s June 6 response to the MIWG citizen petition concerning off-label promotion
  • Sidley Austin LLP
  • USA
  • June 18 2014

On June 6, 2014, FDA sent a letter to counsel for the Medical Information Working Group (MIWG), a coalition of biopharmaceutical and medical


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On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach


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 moves forward with program for Medical Device Development Tools
  • Sidley Austin LLP
  • USA
  • September 8 2014

On August 15, 2014, FDA announced that it is soliciting proposals to participate in a pilot program for Medical Device Development Tools (MDDTs


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


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


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


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