Machine Learning, Prescription Drugs, Innovative Technology

Vital Signs: Digital Health Law Update | Spring 2025

Jones Day on 6/4/2025

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Quit Monkeying Around: FDA Offers Faster Approval Times in Bid to Phase Out Animal Testing

McDermott Will & Schulte on 5/8/2025

On April 10, 2025, the US Food and Drug Administration (FDA) announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug...more

FDA's Recent Release of a Roadmap to Reduce Animal Testing

Morgan Lewis - As Prescribed on 4/28/2025

The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more

IP Toolbox Is Crucial In AI-Powered Drug Discovery

Foley & Lardner LLP on 7/19/2023

Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering. As the cost of developing new drugs...more

Responsible AI: Managing Risk in an Evolving Regulatory and Legal Landscape

Faegre Drinker Biddle & Reath LLP on 10/7/2022

Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...more

New Set Of Guidance From FDA Provides Clarity On Digital Health Policies, Machine Learning

Sheppard Mullin Richter & Hampton LLP on 10/1/2019

On September 26, 2019, the US Food and Drug Administration (FDA) published six guidance documents clarifying its scope of authority and enforcement discretion policies in light of the 21st Century Cures Act (Cures Act). The...more