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Sheppard Mullin's Nota Bene

Apr 17, 2019

The core responsibilities of the Food and Drug Administration (FDA) are to promote public health by reviewing and assuring the safety, effectiveness, quality, and security of drugs, vaccines, medical devices, and several other products.

In this episode, we’re exploring how the FDA operates in the U.S., the types of products it regulates, and how multinational companies can better understand the regulations that relate to their products. Joining me 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.

What We Discussed in this Episode:

  • What is the FDA and how does it function?
  • What types of products the FDA regulates
  • What is digital health and what types of products incorporate this new trend in the health space?
  • How the FDA regulates medical devices that are software-based and includes artificial intelligence
  • Is there any merit to the belief that the U.S. FDA process is more restrictive than similar agencies in foreign countries?
  • How do other countries and their agencies regulate products and how can multinationals analyze the classification of their products in those countries?
  • What’s the difference between clearance and approval by the FDA?
  • What are some recent developments at the agency, especially with a new Commissioner coming in?
  • How does the FDA handle products, food, and supplements with cannabis-derived ingredients in them?

Contact Information:

Allison’s Sheppard Mullin attorney profile

Thank you for listening!

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This podcast is for informational and educational purposes only. It is not to be construed as legal advice specific to your circumstances. If you need help with any legal matter, be sure to consult with an attorney regarding your specific needs.