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The Future of Medical Device Manufacturing Is Here: FDA Issues Draft Guidance on Technical Considerations for 3D Printing
  • K&L Gates
  • USA
  • July 29 2016

A few years ago, a custom-fabricated bioresorbable tracheal splint saved the life of an infant suffering from a collapsed bronchus due to severe

FDA issues draft guidance on diagnostic tests used with targeted drug therapies
  • Arnall Golden Gregory LLP
  • USA
  • July 20 2011

On July 14, 2011, the U.S. Food and Drug Administration (FDA) issued a new draft guidance to facilitate the development and review of companion diagnostics tests designed to be used by healthcare professionals to select the appropriate patient for a particular therapy or to optimize a dosing regimen

IOM report questions health claims based on biomarkers
  • Shook Hardy & Bacon LLP
  • USA
  • May 14 2010

The Institute of Medicine (IOM) this week published a consensus report titled Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, which urges the Food and Drug Administration (FDA) to apply "the same degree of scientific rigor for evaluating biomarker use across regulatory areas, including drugs, medical devices, biologics, foods, and dietary supplements."

LaDale George
  • Perkins Coie LLP

Colin Kavanagh
  • Arthur Cox

Selma Ünlü
  • NSN Law Firm

Sarah H. Stec
  • Squire Patton Boggs