FDA’s regulatory reach touches more than 40% of all products in the market. The Federal Food, Drug and Cosmetic Act (“FDCA”) and its implementing regulations govern a variety of different product types. This product oversight includes both generally recognizable product categories (drugs, medical devices, food and vitamins, cosmetics) and some lesser-known ones (lasers, tobacco, pet treats and vending machine labeling).
This session will provide attendees with an introduction to FDA Regulatory Law and include a discussion of the FDA’s role in the U.S. and the FDCA; several universal industry requirements; and FDA’s enforcement activities and recommended strategies for mitigating that risk. Time will also be spent
taking a closer look at and analyzing three specific topics. These being the regulation of plant-based meat products and genetically modified organisms or GMOs; and dissection of what is a recall and why there are so many.
Presenter Background: Karl focuses on FDA regulatory law at Michael Best & Friedrich in the Firm’s Washington, DC office. He has practiced for 20+ and works with food, drug and device clients on strategies for legal compliance, product approvals and market entry. He is currently working out of the
Firm’s Milwaukee office until the end of February.
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