Moonshot Series: Combating Covid

IRVINE, Calif., November 22, 2024 – Knobbe Martens is pleased to share that partners Steve Jensen and Joseph Re have been named to the OC500, Orange County Business Journal’s annual...

On October 2, 2024, the U.S. Department of Agriculture (USDA), U.S. Environmental Protection Agency (EPA), and U.S. Food and Drug Administration (FDA) released a new web-based interactive tool on the Unified Website for Biotechnology Regulation for companies that develop microbial biotechnology products. The purpose of the tool is to help developers fulfill the regulatory requirements necessary to work with genetically modified microorganisms. The tool defines "genetic modification" as any technique that uses recombinant, synthesized, or amplified nucleic acids to modify or create a genome. “Microorganisms” include prokaryotes (e.g., bacteria and archaea), protists (e.g., amoebas), fungi (e.g., yeast, mold, mushrooms), green and red algae, and viruses or virus-like particles. Through a series of prompts, the tool provides users with information on regulatory requirements and the approval process across agencies. A built-in feedback function allows stakeholders to submit feedback directly to the agencies, which have expressed a commitment to continuing to improve the tool and expand its utility, scope and user base.

In the Bloomberg Law article “FTC’s Marriott Data Breach Order Echoes States’ Right to Delete,” partner Mauricio Uribe offered his perspective on Federal and state privacy law compliance, specifically with...