We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results: 1-10 of 86

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FDA Issues Draft Guidance for Clinical Evaluation of Software As A Medical Device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Last month, the US Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) issued a Draft Guidance for Industry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On Nov. 8, the FDA finalized its 2013 draft guidance on the Medical Device Reporting (MDR) regulation.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


FDA Initiates Its “Healthy” Review of Nutrient Content Claims
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • October 5 2016

On September 28, the U.S. Food and Drug Administration (FDA or the Agency) published a Request for Information regarding FDA’s intent to update the


Key Conventional Food & Dietary Supplement Regulatory Developments That (May Have) Occurred While You Were on Summer Vacation
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • September 9 2016

Weren't able to squeeze the legal press into your summer reading list? No one has to know. This Advisory provides an overview of the nine key US Food


Time for a Reboot: FDA Issues Draft Guidance on When to Submit a 510(k) for a Software Change to an Existing Device
  • Arnold & Porter Kaye Scholer LLP
  • USA
  • September 7 2016

In early August 2016, the US Food and Drug Administration’s (FDA or Agency) Center for Device and Radiological Health (CDRH) issued a Draft Guidance


FDA proposes important revisions to good laboratory practices regulations
  • Arnold & Porter Kaye Scholer LLP
  • USA, OECD
  • August 30 2016

On August 24, 2016, the Food and Drug Administration (FDA) published a proposed rule which would amend the decades-old regulations governing good