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Knobbe Martens
Mar 25, 2025
FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers
Written by: Douglas W. Crandell, Ph.D. and Eric Furman, Ph.D. Drug development programs face unique challenges in demonstrating the safety and... Read More
Knobbe Martens
Mar 4, 2025
Global Market Size and Technological Advancements for Implantable Medical Devices Continue to Grow
Written by: Arash Pia A recent report by Precedence Research estimates the global market size for implantable medical devices will grow from... Read More
Knobbe Martens
Jan 23, 2025
FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development
Written by: Ningxi Sun The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations... Read More
Knobbe Martens
Dec 10, 2024
Novo Nordisk Seeks to Block Compounded Versions of Diabetes / Weight Loss Drug
Written by: Makoto Tsunozaki, Ph.D. & Agnes Juang, Ph.D. On October 22, 2024, Novo Nordisk made a submission to the U.S.... Read More
Knobbe Martens
Nov 22, 2024
FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and Clinical Research
Written by: Douglas W. Crandell, Ph.D. and Joseph Mallon, Ph.D. A recent article[1] authored by Haider J. Warraich, MD[2]; Troy Tazbaz[3];... Read More
Knobbe Martens
Nov 13, 2024
New Tool From EPA, FDA, and USDA Guides Developers of Genetically Modified Microorganisms Through Regulatory Landscape
Written by: Susan M. Janicki, Ph.D. & Robert J. Hilton, Ph.D. On October 2, 2024, the U.S. Department of Agriculture (USDA),... Read More