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Results: 1-10 of 23

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


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On January 16, 2015, FDA issued two draft guidance documents: "General Wellness: Policy for Low Risk Devices," which recommends a hands-off approach


FDA draft guidance on mobile apps signals increased regulatory oversight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On July 20, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance identifying the mobile device applications“apps”the agency plans to regulate as medical devices


New draft guidance on companion diagnostics signals new responsibilities for pharma and dx companies and clinical laboratories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On July 14, U.S. Food and Drug Administration (FDA or the Agency) issued a draft guidance on In Vitro Companion Diagnostic Devices


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


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 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 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


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