Nota Bene Episode 32: A Snapshot of the FDA: Understanding the Basics of Regulations with Allison Fulton


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 host 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 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?


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