Novo Nordisk Seeks to Block Compounded Versions of Diabetes / Weight Loss Drug
On October 22, 2024, Novo Nordisk made a submission to the U.S. Food and Drug Administration (FDA) nominating Novo Nordisk’s semaglutide products (WEGOVY, OZEMPIC and RYBELUS) to be included in...
Daniel Kamkar and Adam Powell Named Among 2024 Leaders of Influence in Law by San Diego Business Journal
SAN DIEGO, October 31, 2024 – Knobbe Martens is pleased to share that partners Daniel Kamkar and Adam Powell were profiled in San Diego Business Journal’s (SDBJ) 2024 Leaders of...
New Tool From EPA, FDA, and USDA Guides Developers of Genetically Modified Microorganisms Through Regulatory Landscape
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.
