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 39

FDA Announces Regulatory and Enforcement Policy Shift for Regenerative Medicine
  • Sidley Austin LLP
  • USA
  • September 13 2017

On August 28, 2017, FDA Commissioner Scott Gottlieb announced a significant shift in the way the Agency intends to regulate stem cell therapies and


New Guidance Reflects Heightened FDA Focus on Medical Device Cybersecurity
  • Sidley Austin LLP
  • USA
  • January 26 2016

On January 15, 2016, the Food and Drug Administration (FDA) issued new guidance that, for the first time, recommends routine postmarketing


FDA draft guidance on mobile apps signals increased regulatory oversight
  • Sidley Austin LLP
  • USA
  • July 27 2011

On July 20, 2011, the U.S. Food and Drug Administration (FDA) issued draft guidance identifying the mobile device applications“apps”the agency plans to regulate as medical devices



Coleen Klasmeier
  • Sidley Austin LLP

Colleen Theresa Brown
  • Sidley Austin LLP

Allison Fulton
  • Sidley Austin LLP

Andrew W. Stern
  • Sidley Austin LLP

Anna L.Spencer
  • Sidley Austin LLP

Daniel A. McLaughlin
  • Sidley Austin LLP