The U.S. Food and Drug Administration said Wednesday it worked jointly with the Environmental Protection Agency and the Department of Agriculture to develop a regulatory plan for products on biotechnology.
The plan, which came in response to an executive order from President Joe Biden, updates, streamlines and clarifies regulations and oversight mechanisms, the FDA said.
The agencies focused on five areas: modified plants; modified animals; modified microorganisms; human drugs, biologics and medical devices; and cross-cutting issues, and worked with developers and stakeholders, to collaboratively develop the plan, according to the FDA.
The plan includes processes and timelines to implement regulatory reform and identify potential needs for new guidance or regulations, the FDA said, adding that it supports a whole-of-government approach to the regulation of biotechnology products.
The agencies intend to clarify and streamline regulatory oversight for genetically engineered plants, animals and microorganisms, as well as to undertake a pilot project focused on modified microbes to explore developing a web-based tool to informs developers about which agency may regulate a given product category, among other projects.
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