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July 31, 2019 @ 12:00 pm - 1:30 pm
If you’re just starting to learn about how and why the FDA regulates biomedical products, then join us for this one-hour session. We will review what products are regulated, how they are regulated, and how you can learn more. The authority of the FDA stems from Acts of Congress, which ultimately are codified into federal regulations, and we’ll review how this process occurs. The FDA generally wants to assure the safety, efficacy and quality of the products it regulates, but it provides very specific recommendations to industry on how to achieve those goals. We’ll review how to find this information, and provide some general information on the likely timelines and costs to bring biomedical products to market.
Check-in starts at 11:30 and the presentation will begin at 12.
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