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EPA, FDA, and USDA Release Tool to Help Biotechnology Developers Navigate Regulatory Landscape
Posted by: Prof. Dr. M. Raupp (IP Logged)
Date: November 06, 2024 05:42PM

On October 2, 2024, the U.S. Department of Agriculture (USDA), the U.S.
Environmental Protection Agency (EPA), and the U.S. Food and Drug
Administration (FDA) launched the Unified Website for Biotechnology
Regulation, a new web-based tool for companies developing microbial
biotechnology products.



The unified website provides information on regulatory requirements and
approval processes for biotechnology products with genetically modified (GM)
microorganisms. This tool could serve as a guide for new and existing
researchers and developers in understanding the regulatory requirements for
GM microorganisms. The agencies plan to further optimize the website through
a feedback option that allows users to provide feedback directly to the
agencies.



This initiative supports the objectives of Executive Order (EO) 14081 by
promoting public trust in the biotech regulatory system and enhancing its
transparency, consistency, coordination, and efficiency. In line with EO
14081, the USDA and EPA are also working to harmonize data requirements to
improve data sharing and avoid redundant reviews.



[www.aphis.usda.gov]
p-biotechnology-developers-navigate-regulatory



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