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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


“Challenges Remain” for FDA’s Inspections of Food Facilities, According to Inspector General Report
  • Kelley Drye & Warren LLP
  • USA
  • October 2 2017

While FDA is on track to meet the initial inspection timeframes specified under the Food Safety Modernization Act (FSMA), questions remain about the


Three Reasons “Natural” Class Actions Are Here to Stay
  • Kelley Drye & Warren LLP
  • USA
  • September 28 2017

In a review of new class action cases filed against in 2017, we counted at least 11 actions in the food industry alone alleging that a product was not


Does the NAD’s Capillus Decision Baldly Contradict the FDA?
  • Kelley Drye & Warren LLP
  • USA
  • September 20 2017

On September 12, the NAD released its decision in its review of the Capillus82 hair growth device (Case 6107). This case is unusual in that it


Minnesota Federal Judge Says Glyphosate Claims are “Unreasonable”
  • Kelley Drye & Warren LLP
  • USA
  • July 14 2017

A mini-trend in food litigation last year was the spate of class action cases alleging that foods advertised as “natural” contained trace amounts of