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Results: 1-10 of 41

FDA Clears mHealth App That Uses AI to Signal Signs of Stok
  • Kelley Drye & Warren LLP
  • USA
  • February 28 2018

FDA announced last week that it has cleared for marketing an mHealth app that uses artificial intelligence (AI) to analyze CT images for signs of


Think Your Prescription Drug Advertising is Beyond NAD’s Purview? NAD Disagrees.
  • Kelley Drye & Warren LLP
  • USA
  • February 6 2018

Those of us who spend our days at the intersection of law and advertising of health products generally accept that the prescription drug world is a


FDA Releases 2018 Roadmap: Focus On Digital Health Continues
  • Kelley Drye & Warren LLP
  • USA
  • January 16 2018

Last week, FDA released a document outlining its policy priorities for the coming year. “Healthy Innovation, Safer Families: FDA’s 2018 Strategic


H.R. 3985 Calls For Public-Private Working Group to Study Medical Device Security
  • Kelley Drye & Warren LLP
  • USA
  • October 18 2017

The “Internet of Medical Things Resiliency Partnership Act of 2017” was introduced in the House of Representative earlier this month. Co-sponsored by


FDA and EPA Issue Joint Guidance On Jurisdiction Over Mosquito-Related Products
  • Kelley Drye & Warren LLP
  • USA
  • October 12 2017

Last week, FDA and the EPA issued guidance for industry regarding each agency’s respective jurisdiction over mosquito-related products. With the


Digital Health Update: Tech and Health Care Giants Selected for FDA’s Pre-Cert Program
  • Kelley Drye & Warren LLP
  • USA
  • October 11 2017

In his keynote address at the AdvaMed annual conference in late September, FDA Commissioner Scott Gottlieb returned to the themes of promoting


Senate Expected to Vote on Gottlieb Nomination Next Week
  • Kelley Drye & Warren LLP
  • USA
  • May 4 2017

Today, Senate Majority Leader Mitch McConnell (R-KY) filed cloture on the nomination of Dr. Scott Gottlieb to be the next FDA Commissioner. A cloture


FDA Commissioner Nominee Gottlieb Written Responses Signal Support for Food Safety and Science-Based Approach to Consumer Communications
  • Kelley Drye & Warren LLP
  • USA
  • April 27 2017

Dr. Scott Gottlieb, recently submitted written responses to questions posed by members of the Senate Health, Education, Labor and Pensions Committee


Senate Hearing on FDA Commissioner Nominee Scott Gottlieb Provides Insights on the Future of Food Safety and Labeling
  • Kelley Drye & Warren LLP
  • USA
  • April 13 2017

Last Wednesday, April 5, the Senate Committee on Health, Education, Labor, & Pensions held a hearing on the nomination of Scott Gottlieb, MD, as


NY AG Enters Mobile Health App Enforcement Arena with Settlements Targeting Health Claims and Privacy Practices
  • Kelley Drye & Warren LLP
  • USA
  • April 11 2017

New York Attorney General Eric Schneiderman recently announced settlements with three mobile health app developers resolving allegations that they