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Results:1-10 of 104

Former FDA Senior Regulatory and Policy Counsel Bryant Godfrey Joins Arnold & Porter
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • June 12 2018

Arnold & Porter announced today that Bryant M. Godfrey, former Senior Regulatory Counsel in the US Food and Drug Administration’s Centers for Drug


National Right to Try Legislation Passes Congress
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • May 23 2018

On May 22, 2018, the United States House of Representatives passed 250-169 the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Mathew Bellina


FDA and USDA Action Implements US Nutrition Action Plan and Federal Food Labeling Policy Agenda
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • May 14 2018

This year has been marked by robust efforts by the Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) to


FDA Objects to Branded Pre-Approval YouTube Video
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • January 3 2017

We thought our readers might be interested in a recent Untitled Letter that FDA sent to Zydus Discovery DMCC, the US agentsubsidiary of Indian


Recommended Reading: Advisory on the 21st Century Cures Act
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • December 21 2016

The 21st Century Cures Act (Cures Act) was signed into law on December 13, 2016, following a multi-year, bipartisan, and bicameral legislative effort


The 21st Century Cures Act
  • Arnold & Porter Kaye Scholer LLP
  • USA, United Kingdom
  • December 16 2016

Following a multi-year, bipartisan, and bicameral effort to accelerate the pace of the discovery, development, and delivery of new treatments...


FDA unveils new website for anonymous reporting of regulatory violations
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • December 5 2016

The Food and Drug Administration (FDA) recently introduced a new webpage for reporting allegations of regulatory violations by medical device


FDA Issues Draft Guidance for Clinical Evaluation of Software As A Medical Device
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • November 22 2016

Last month, the US Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) issued a Draft Guidance for Industry


FDA Releases Final Guidance on Medical Device Reporting for Manufacturers
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • November 18 2016

On Nov. 8, the FDA finalized its 2013 draft guidance on the Medical Device Reporting (MDR) regulation. The guidance supersedes the FDA's previous


Post-Election Analysis 2016: Healthcare, Life Sciences & FDA
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • November 9 2016

Transition Team for Healthcare Rich Bagger - Executive Vice President at Celgene Corp. Jamie Burke - Principal at Burke Consulting, LLC Healthcare