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Document of the Week...

Medical Products: Pathways to Market

When evaluating a product, FDA weighs the potential benefits of a medical product against potential harm, so Congress and FDA have established both premarket and postmarket requirements for medical products,including expedited development and review pathways. In this way, Congress and FDA have acknowledge the trade-off between reducing time to marketing and a potentially less complete safety profile upon approval. This December 2019 report was prepared by the Congressional Research Service to summarize various approval pathways for drugs and devices.

Featured until February 25, 2020. Click here to download.