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Results: 1-10 of 135

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


Clinical trials in China
  • Ropes & Gray LLP
  • China, Global
  • March 15 2018

A structured guide to clinical trials in China


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On Dec. 8, 2017, the U.S. Food and Drug Administration issued two draft guidance documents that describe types of software functions that the FDA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On December 8, 2017, the U.S. Food and Drug Administration ("FDA") issued two draft guidance documents that describe types of software functions that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


What To Know About New FDA Informed Consent Guidance
  • Ropes & Gray LLP
  • USA
  • August 14 2017

On July 25, 2017, the U.S. Food and Drug Administration issued a guidance document announcing its intention not to object to an institutional review


A Modern Approach To Digital Health Product Regulation
  • Ropes & Gray LLP
  • USA
  • August 7 2017

As part of an overarching initiative to update its regulatory oversight of digital health technologies, the U.S. Food and Drug Administration has


FDA User Fee Reauthorization Legislation Enacted by Congress
  • Ropes & Gray LLP
  • USA
  • August 7 2017

On July 12, 2017, the House of Representatives passed H.R. 2430, the FDA Reauthorization Act of 2017 (FDARA), and on August 3, 2017, the Senate


FDA Announces New Digital Health Innovation Programs
  • Ropes & Gray LLP
  • USA
  • July 28 2017

As part of an overarching initiative to update its regulatory oversight of digital health technologies, the Food and Drug Administration (“FDA”) has


FDA Issues Immediately Effective Guidance Allowing Waiver of Informed Consent for Minimal Risk Research
  • Ropes & Gray LLP
  • USA
  • July 25 2017

The United States Food & Drug Administration (FDA) has issued a guidance document announcing its intention not to object to an IRB’s waiving or