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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 & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal
  • Kelley Drye & Warren LLP
  • USA
  • January 24 2018

The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved


FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal
  • Kelley Drye & Warren LLP
  • USA
  • January 24 2018

The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved


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


Louisiana Adopts Price Reporting Law
  • Kelley Drye & Warren LLP
  • USA
  • November 13 2017

A new law in Louisiana requires drug manufacturers to report wholesale acquisition cost (WAC) information directly to the state. Louisiana law defines


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


Love Is a Many-Spendored Thing, but It’s Not an Ingredient
  • Kelley Drye & Warren LLP
  • USA
  • October 10 2017

The Food and Drug Administration has made the news lately for disapproving a Massachusetts bakery’s inclusion of “love” among the listed ingredients