[20191204]IF11379_医疗产品创新与监管：好处和风险 .pdf

https:/crsreports.congress.gov December 4, 2019Medical Product Innovation and Regulation: Benefits and Risks Prior to being marketed in the United States, medical products are reviewed for safety and effectiveness, among other things, by the Food and Drug Administration (FDA). Medical products regulated by FDA include prescription drugs, medical devices, and biologics. When evaluating a product, FDA weighs the potential benefits of a medical product against the potential for certain harms associated with the use of that same product. It is in this context that Congress and FDA have established both premarket and postmarket requirements for medical products, as well as expedited development and review pathways for certain medical products for serious diseases with few available treatment options. In establishing these expedited pathways, Congress and FDA have acknowledged an implicit trade-off between reducing time to marketing and a potentially less complete safety profile upon approval. History of Medical Product Regulation The Biologics Control Act of 1902 (P.L. 57-244) was the first attempt to regulate a pharmaceutical product at the national level. It was also the first premar