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Results:1-10 of 81

US FDA Approaches to Artificial Intelligence
  • Drinker Biddle & Reath LLP
  • USA
  • April 24 2018

Artificial Intelligence (AI) can be employed in a health care setting for a variety of tasks, from managing electronic health records at a hospital


FDA Approves Software Application That Alerts Providers of Potential Stroke in Patients
  • Drinker Biddle & Reath LLP
  • USA
  • February 23 2018

On February 13, 2018 FDA approved a software application with clinical-decision support capability, in this case alerting providers of a potential


FDA Issues New Draft Guidance on “Least Burdensome” Principles for Medical Devices
  • Drinker Biddle & Reath LLP
  • USA
  • December 21 2017

On December 15, the U.S. Food & Drug Administration (FDA) issued “The Least Burdensome Provisions: Concept and Principles: Draft Guidance for Industry


FDA Approves First Digital Pill
  • Drinker Biddle & Reath LLP
  • USA
  • November 17 2017

The U.S. Food and Drug Administration has approved the country’s first drug with a digital ingestion tracking system. Abilify MyCite is a pill that


Made in the USA: Labeling Lawsuits in America's Pet Food Industry
  • Drinker Biddle & Reath LLP
  • USA
  • March 8 2016

As of 2015, the Food & Drug Administration (FDA) had become aware of more than 5,000 reports of American dogs that became sick or died after eating


Federal court grants First Amendment injunction in Amarin case
  • Drinker Biddle & Reath LLP
  • USA
  • August 7 2015

Federal Court Grants Requested Injunction in Amarin: Confirms Caronia Stands for Proposition that "the government cannot prosecute pharmaceutical


FDA releases Draft Guidance on its Voluntary Qualified Importer Program
  • Drinker Biddle & Reath LLP
  • USA
  • July 2 2015

On June 5, 2015, the Food and Drug Administration (FDA) announced the publication of its Draft Guidance on its Voluntary Qualified Importer Program


FDA issues guidance on cybersecurity for medical devices
  • Drinker Biddle & Reath LLP
  • USA
  • November 24 2014

On October 2, the FDA issued guidance on cybersecurity for medical devices containing software in order "to assist industry by identifying issues


FDA and CBP to begin new pilot programs
  • Drinker Biddle & Reath LLP
  • USA
  • August 21 2013

Both the Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) are expected to begin pilot programs to give additional


“Dear doctor” letters: FDA removes behavior tracking recommendations from proposed guidance
  • Drinker Biddle & Reath LLP
  • USA
  • August 6 2013

On July 9, 2013, the United States Food and Drug Administration (FDA) announced a modification of certain recommendations contained in the November