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So you’ve made a new product by genetically engineering a living organism, and are eager to sell it in the United States. Before it gets to market, however, you’ll need to answer a critical question: Which U.S. agency has to sign off on its safety? The U.S. Food and Drug Administration (FDA), Department of Agriculture (USDA), and Environmental Protection Agency (EPA) might all lay claim to a product made through synthetic biology, depending on the method of production and its intended use. But many new technologies don’t fit neatly into the purview of one office, concludes a report released today.
In the report, penned by the Synthetic Biology Project at the Woodrow Wilson International Center for Scholars, a Washington, D.C.–based think tank, a team of regulatory experts describe just how tortuous the path to market could be for new biotech products. It serves as a warning to startup companies that they’ll likely need to visit multiple agencies early in the development process, says Todd Kuiken, the Synthetic Biology Project’s principle investigator.
This summer, the White House acknowledged...