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Results: 1-10 of 141

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FDA Issues Draft Guidance Regarding Waiver of Single Shared System REMS Requirement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Lessons From FDA Draft Guidance On Multifunctional Devices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On April 27, 2018, the U.S. Food and Drug Administration issued draft guidance on the regulation of devices with multiple functions.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FDA Issues Draft Guidance on Devices with Multiple Functions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On April 27, 2018, FDA issued draft guidance on the regulation of devices with multiple functions. The draft guidance implements a requirement of the


Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
  • Ropes & Gray LLP
  • USA
  • April 12 2018

The rules regarding truthful, non-misleading communications by medical product manufacturers have long been unclear. In recent years, there have been


The Latest FDA Move To Limit Digital Health Software Regs
  • Ropes & Gray LLP
  • USA
  • December 22 2017

On Dec. 8, 2017, the U.S. Food and Drug Administration issued two draft guidance documents that describe types of software functions that the FDA


FDA Issues Draft Guidances to Scale Back Regulation of Digital Health Software
  • Ropes & Gray LLP
  • USA
  • December 13 2017

On December 8, 2017, the U.S. Food and Drug Administration ("FDA") issued two draft guidance documents that describe types of software functions that


ITC Defers to FDA, Declining to Institute Section 337 Investigation
  • Ropes & Gray LLP
  • USA
  • October 31 2017

In what represents a departure from typical U.S. International Trade Commission (ITC) practice, the ITC on October 27, 2017 declined to institute a