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Autonomous Vehicles 2016
  • Borden Ladner Gervais LLP
  • Canada, USA
  • July 27 2016

Some of the largest and most influential companies in the world have made billion-dollar investments in “driverless transport” - and these are not


ACI Medical Devices Boot Camp Features New CDRH Director of Clinical Compliance Robin Newman
  • McGuireWoods LLP
  • USA
  • July 26 2016

On July 21-22, the American Conference Institute (ACI) held its Fourth Annual FDA Boot Camp: Medical Devices Edition in Chicago, Illinois. The


FDA Deep Dive: Real Life Implications of FDA NEST Program Explored
  • Mintz Levin Cohn Ferris Glovsky and Popeo PC
  • USA
  • July 19 2016

In our Israel Connect Summer 2016 edition we summarized the FDA's post-market surveillance data programs, including the NEST program designed to


FDA Releases Two Draft Guidances on Next Generation Sequencing
  • Hogan Lovells
  • USA
  • July 15 2016

On July 6, 2016, the FDA announced two new draft guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests


FDA Issues Final Rule on Use of Stand-Alone Symbols in Medical Device Labeling
  • Hogan Lovells
  • USA
  • June 24 2016

On June 14, 2016, the Food and Drug Administration ("FDA" or "the agency") issued a final rule entitled Use of Symbols in Labeling. Historically, FDA


FDA Issues Draft Guidance on Benefit-Risk Factors to Consider Regarding Medical Device Availability, Compliance, and Enforcement
  • Barnes & Thornburg LLP
  • USA
  • June 21 2016

The Food and Drug Administration (FDA) recently issued a brief draft guidance titled "Factors to Consider Regarding Benefit-Risk in Medical Device


FDA Issues First Draft Guidance on NGS-Based Diagnostic Devices
  • Hogan Lovells
  • USA
  • June 2 2016

On May 13, 2016, the U.S. Food and Drug Administration (FDA or the Agency) issued a new draft guidance entitled, "Infectious Disease Next Generation


Pharmaceutical & Medical Device Regulatory Update, Vol. III, Issue 4
  • Jones Day
  • USA
  • May 31 2016

Earlier this month, four Republican SenatorsLamar Alexander (TN), Richard Burr (NC), Johnny Isakson (GA), and Orrin Hatch (UT)sent a letter to FDA


FDA addresses postmarket surveillance for medical devices in final guidance
  • Barnes & Thornburg LLP
  • USA
  • May 31 2016

The Food and Drug Administration (FDA) recently issued a final guidance addressing postmarket surveillance for medical devices. The FDA is authorized


International Corporate Crime Conference Report
  • CMS
  • European Union, United Kingdom, USA
  • May 27 2016

Allegations of fraud, corruption, money laundering, tax evasion and other forms of financial crime involving senior public figures and companies are