Nota Bene Episode 71: Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton


2019 ushered in numerous changes and new initiatives at the U.S. Food and Drug Administration (FDA). From the increasing popularity of cannabis use to the rapidly evolving nature of artificial intelligence in medical devices, we’re reflecting on some of the initiatives the FDA tackled in 2019 and exploring what lies ahead for the agency in 2020.

Joining Michael Cohen for this conversation is Allison Fulton. Allison is a partner in the Life Sciences and FDA team and is based in Sheppard Mullin’s Washington, D.C. office. Allison advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food and cosmetic companies, in matters relating to the development, manufacture, and marketing of products regulated by the U.S. FDA.

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What We Discuss in This Episode:

  • What role does the FDA play in public health and safety, especially when epidemics like the coronavirus threaten global health?
  • Are we all overreacting to the impact of the coronavirus? What is the right approach to addressing fears?
  • What updates and changes were made by the FDA in 2019 under the new commissioner?
  • The shifting public opinion regarding cannabis products and the impact on regulation
  • How has the lack of data relating to CBD effected the progress of FDA regulation?
  • Is the FDA still relevant when many cannabis product manufacturers already produce and distribute products without FDA regulation?
  • What components of vaping products cause the most damage to the human body?
  • What is the FDA doing to try to regulate vaping products?
  • Is technology in medical products evolving at a faster rate than the FDA can keep up with?
  • What is the FDA’s post-market device regulation model?
  • What are some of the major issues the FDA is likely to focus on in 2020?
  • What safeguards exist to protect biologic innovators?
  • What are compounding pharmacies and how can they help patients?


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