We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

Search results

Order by: most recent most popular relevance



Results:1-10 of 177

FDA Issues Draft Guidance Encouraging Innovative Approaches to Expand Access to OTC Drugs
  • Kelley Drye & Warren LLP
  • USA
  • July 30 2018

FDA recently released a new draft guidance, “Innovative Approaches for Nonprescription Drug Products,” that described two “innovative approaches” that


FDA Releases Guidance Regarding Strategies to Protect Against Food Adulteration
  • Kelley Drye & Warren LLP
  • USA
  • July 2 2018

On June 20, 2018, the FDA released draft guidance regarding the FDA’s Mitigation Strategies to Protect Food Against Intentional Adulteration Rule (IA


FDA Releases First in Series of Draft Guidances Regarding Mitigation Strategies to Protect Against Intentional Adulteration
  • Kelley Drye & Warren LLP
  • USA
  • July 2 2018

On June 20, 2018, the Food and Drug Administration (“FDA”) released draft guidance for companies required to comply with the FDA’s final rule


Senator Schumer Introduces Legislation to Decriminalize Marijuana at the Federal Level
  • Kelley Drye & Warren LLP
  • USA
  • June 29 2018

Making good on this April 20th announcement, Senator Chuck Schumer (D-NY) introduced legislation that would upend current federal regulation of


FDA to Hold Public Meeting on Foods Produced Using Animal Cell Culture Technology
  • Kelley Drye & Warren LLP
  • USA
  • June 20 2018

The FDA recently announced that it will hold a public meeting entitled, “Foods Produced Using Animal Cell Culture Technology,” on July 12, 2018 to


USDA and FDA Announce Proposed Bioengineered Disclosure Rules and Labeling Rule Compliance Date Changes
  • Kelley Drye & Warren LLP
  • USA
  • May 15 2018

Both the USDA and the FDA recently released updates to food labeling regulations that will significantly affect food manufacturers. On Friday, May 4


FDA Commissioner Continues To Roll Out Digital Health Initiatives
  • Kelley Drye & Warren LLP
  • USA
  • May 7 2018

FDA Commissioner Scott Gottlieb trumpeted the agency’s “modern and flexible” approach to digital health regulation when speaking at Health Datapalooza


Unanimous Recommendation for Cannabis-Based Epilepsy Drug; Trump Administration Lifts Threat of Cannabis Enforcement in States With Legalization; Schumer To Introduce Bill Decriminalizing Marijuana
  • Kelley Drye & Warren LLP
  • USA
  • April 20 2018

On this auspicious April 20th, three developments in the world of cannabis regulation caught our attention. The first is the unanimous recommendation


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