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Results:1-10 of 117

Life Sciences: Compliance and enforcement in China
  • Ropes & Gray LLP
  • China, Global
  • July 31 2018

A structured guide to compliance and dishonest practices in China


Life Sciences: product regulation and liability in China
  • Ropes & Gray LLP
  • China, Global
  • July 31 2018

A structured guide to product regulation and liability laws in China


Clinical trials in China
  • Ropes & Gray LLP
  • China, Global
  • July 31 2018

A structured guide to clinical trials in China


Pharmacovigilance in China
  • Ropes & Gray LLP
  • China, Global
  • July 31 2018

A structured guide to Pharmacovigilance in China


FDA Clarifies Communication Rules for Medical Product Companies
  • Ropes & Gray LLP
  • USA
  • June 22 2018

On June 12, 2018, the U.S. Food and Drug Administration issued two key documents outlining the agency's current thinking regarding drug and device


FDA Issues Final Guidance Documents Relating to Medical Product Manufacturer Communications
  • Ropes & Gray LLP
  • USA
  • June 15 2018

On June 12, 2018, the Food and Drug Administration (“FDA”) issued two key documents outlining the agency’s current thinking regarding drug and device


FDA Issues Draft Guidance Regarding Waiver of Single Shared System REMS Requirement
  • Ropes & Gray LLP
  • USA
  • June 13 2018

FDA Commissioner Scott Gottlieb has vowed to take steps to speed the review and approval of generic drugs as part of his overall priority to address


Lessons From FDA Draft Guidance On Multifunctional Devices
  • Ropes & Gray LLP
  • USA
  • May 24 2018

On April 27, 2018, the U.S. Food and Drug Administration issued draft guidance on the regulation of devices with multiple functions. The draft


A Look Inside Trump's 4-Point Plan For Curbing Drug Prices
  • Ropes & Gray LLP
  • USA
  • May 18 2018

On May 11, President Donald Trump outlined his administration’s four-point plan for curbing prescription drug prices. With rare exceptions, the plan


FDA Issues Draft Guidance on Devices with Multiple Functions
  • Ropes & Gray LLP
  • USA
  • May 14 2018

On April 27, 2018, FDA issued draft guidance on the regulation of devices with multiple functions. The draft guidance implements a requirement of the